`By WP Heim on November 21, 2015
`https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/results.cfm
`Sorted by Event Date (column G)
`
`Web Address
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=606433
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=606433
`
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=889138
`
`Manufactu
`Report
`rer
`Number
`606433 DATEX‐
`OHMEDA
`
`Brand Name
`
`INOVENT
`
` Product
`Date Report
`Code
`Received
`5/13/2005 MRN
`
`606433 DATEX‐
`OHMEDA
`
`INOVENT
`
`5/13/2005 MRN
`
`2112667‐
`2006‐
`00056
`
`GE
`HEALTHCA
`RE
`
`INOVENT
`
`9/29/2006 MRN
`
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=880307
`
`2112667‐
`2006‐
`00057
`
`GE
`HEALTHCA
`RE
`
`INOVENT
`
`9/29/2006 MRN
`
`Note: report number MW1042540 omitted because it is clearly an error (reports on GENZYME SEPRA MESH Hernia repair)
`
`Event Date
`
`Event Type
`
`Event Text
`
`3/16/2005 Malfunction Event Description: INOVENT WAS DISPLAYING "WEAK NO CELL" IN DISPLAY WINDOW. A NEW CELL WAS INSTALLED; AS PER MANUFACTURER
`RECOMMENDATIONS. THE MACHINE ALARMED DELIVERY AND FAILURE SHUT DOWN. AN ATTEMPTED RESTART AND PURGE WERE NOT SUCCESSFUL.
`SAME DISPLAY OCCURRED. THE PATIENT WAS DECOMPENSATING; BAGGED AND THE ENTIRE MACHINE WAS CHANGED OUT. THE MACHINE WAS
`TAKEN OUT OF SERVICE AND RETURNED TO THE RENTAL COMPANY.
`
`3/16/2005 Malfunction Event Description: INOVENT WAS DISPLAYING "WEAK NO CELL" IN DISPLAY WINDOW. A NEW CELL WAS INSTALLED; AS PER MANUFACTURER
`RECOMMENDATIONS. THE MACHINE ALARMED DELIVERY AND FAILURE SHUT DOWN. AN ATTEMPTED RESTART AND PURGE WERE NOT SUCCESSFUL.
`SAME DISPLAY OCCURRED. THE PATIENT WAS DECOMPENSATING; BAGGED AND THE ENTIRE MACHINE WAS CHANGED OUT. THE MACHINE WAS
`TAKEN OUT OF SERVICE AND RETURNED TO THE RENTAL COMPANY.
`
`4/1/2006 Malfunction Event Description: ACCORDING TO THE SUSPECT ADVERSE EVENT REACTION REPORT RECEIVED FROM INOT; "A NURSE WAS CHANGING OVER AN
`EMPTY INOMAX CYLINDER FOR A NEW ONE WHILE ON A PATIENT. ANOTHER STAFF MEMBER WAS READING THE INSTRUCTIONS. ON TURNING THE
`NEW CYLINDER ON; IT SOUNDED LIKE A HISS WHICH WAS THOUGHT TO BE A LOW LEVEL LEAK. THE NURSE WAS ABOUT TO INVESTIGATE FURTHER
`WHEN A TORRENTIAL LEAK OCCURRED WITH A REPORTED PROMINENT SMELL OF NITRIC OXIDE GAS. THE CYLINDER WAS TURNED OFF AND THE
`NURSE LEFT THE ROOM. ABOUT ONE HOUR AFTER THE INCIDENT; THE NURSE WAS SEEN IN A&E DEPT. FOR COMPLAINTS OF TIGHTENING IN THE
`CHEST AND PAIN SIMILAR TO BRONCHITIS. HE RECEIVED TREATMENT WITH O2 AND WAS HOSPITALIZED OVERNIGHT. THE OTHER TWO STAFF
`MEMBERS PRESENT DURING THE EVENT ALSO DEVELOPED CHEST TIGHTNESS AND WERE ATTENDED TO IN THE A&E DEPT. BUT RETURNED STRAIGHT
`TO DUTY WITH NO FURTHER SIDE EFFECTS. FOLLOWING DISCHARGE IN 2006; THE NURSE HAS DEVELOPED FOUR EPISODES OF SUDDEN CHEST
`TIGHTENING AND DIFFICULTY BREATHING. DURING A FOLLOW‐UP VISIT AT THE HOSPITAL; THE DOCTOR THOUGHT THE EVENTS MIGHT CONTINUE
`FOR THE NEXT 3 WEEKS DUE TO AN INHALATION INJURY. THE NURSE HAS REPORTED BREATHING DIFFICULTIES ONCE PER WEEK AT THE TIME OF THE
`REPORT WITH HOPE THAT THEY WILL RESOLVE COMPLETELY. THE SUSPECT ADVERSE EVENT REACTION REPORT STATES THE EVENT INVOLVED A
`NURSE AND TWO STAFF MEMBERS. THIS MEDWATCH REPORT WILL REPRESENT THE FIRST STAFF MEMBER. Manufacturer Narrative:
`INVESTIGATION/CONCLUSION: NO PARTS WERE RETURNED TO GE HEALTHCARE FOR INVESTIGATION. ACCORDING TO THE SUSPECT ADVERSE EVENT
`REACTION REPORT; "THE FAULT SEEMS TO BE THE RUBBER O‐RING ON THE TIP OF THE HIGH PRESSURE ASSEMBLY; CAUSING A BAD PRESSURE SEAL
`PER THE HOSPITAL REPORTER. THE INOVENT; CYLINDER; AND O‐RING CONCERNED WERE REMOVED FROM THE HOSPITAL FOR INVESTIGATION. ALL O‐
`RINGS PREVIOUSLY SENT TO THE HOSPITAL WERE REPLACED IN CASE OF A BATCH PROBLEM. THE HOSPITAL STAFF RECEIVED FURTHER TRAINING ON
`EXPOSURE AND SAFE LEVELS OF NO/NO2 IN THE ATMOSPHERE AND CYLINDER MANAGEMENT." THE DISTRIBUTOR RETURNED THE O‐RING TO THE
`VENDOR FOR INVESTIGATION. THE VENDOR CONFIRMED THE O‐RING WAS DAMAGED. THE INOVENT OPERATION & MAINTENANCE MANUAL
`INDICATES THE CORRECT PROCEDURE TO CONNECT AN NO CYLINDER TO AN INOVENT; HOW TO CHECK FOR LEAKS; AND THE APPROPRIATE ACTION
`TO TAKE IF A LEAK IS DETECTED.
`
`4/1/2006 Malfunction Event Description: ACCORDING TO THE SUSPECT ADVERSE EVENT REACTION REPORT RECEIVED FROM INOT "A NURSE WAS CHANGING OVER AN
`EMPTY INOMAX CYLINDER FOR A NEW ONE WHILE ON A PT. ANOTHER STAFF MEMBER WAS READING THE INSTRUCTIONS. ON TURNING THE NEW
`CYLINDER ON; IT SOUNDED LIKE A HISS WHICH WAS THOUGHT TO BE A LOW LEVEL LEAK. THE NURSE WAS ABOUT TO INVESTIGATE FURTHER WHEN A
`TORRENTIAL LEAK OCCURRED WITH A REPORTED PROMINENT SMELL OF NITRIC OXIDE GAS. THE CYLINDER WAS TURNED OFF AND THE NURSE LEFT
`THE ROOM. ABOUT ONE HOUR AFTER THE INCIDENT; THE NURSE WAS SEEN IN A&E DEPT. FOR COMPLAINTS OF TIGHTENING IN THE CHEST AND PAIN
`SIMILAR TO BRONCHITIS. HE RECEIVED TREATMENT WITH O2 AND WAS HOSPITALIZED OVERNIGHT. THE OTHER TWO STAFF MEMBERS PRESENT
`DURING THE EVENT ALSO DEVELOPED CHEST TIGHTNESS AND WERE ATTENDED TO IN THE A&E DEPT. BUT RETURNED STRAIGHT TO DUTY WITH NO
`FURTHER SIDE EFFECTS. FOLLOWING DISCHARGE ON THE DAY AFTER EVENT DAY; THE NURSE HAS DEVELOPED FOUR EPISODES OF SUDDEN CHEST
`TIGHTENING AND DIFFICULTY BREATHING. DURING A FOLLOW‐UP VISIT AT THE HOSPITAL; THE DOCTOR THOUGHT THE EVENTS MIGHT CONTINUE
`FOR THE NEXT 3 WEEKS DUE TO AN INHALATION INJURY. THE NURSE HAS REPORTED BREATHING DIFFICULTIES ONCE PER WEEK AT THE TIME OF THE
`REPORT WITH HOPE THAT THEY WILL RESOLVE COMPLETELY." THE SUSPECT ADVERSE EVENT REACTION REPORT STATES THE EVENT INVOLVED A
`NURSE AND TWO STAFF MEMBERS. THIS MEDWATCH REPORT WILL REPRESENT THE SECOND STAFF MEMBER. Manufacturer Narrative:
`INVESTIGATION/CONCLUSION: NO PARTS WERE RETURNED TO GE HEALTHCARE FOR INVESTIGATION. ACCORDING TO THE SUSPECT ADVERSE EVENT
`REACTION REPORT; "THE FAULT SEEMS TO BE THE RUBBER O‐RING ON THE TIP OF THE HIGH PRESSURE ASSEMBLY; CAUSING A BAD PRESSURE SEAL
`PER THE HOSPITAL REPORTER. THE INOVENT; CYLINDER; AND O‐RING CONCERNED WERE REMOVED FROM THE HOSPITAL FOR INVESTIGATION. ALL O‐
`RINGS PREVIOUSLY SENT TO THE HOSPITAL WERE REPLACED IN CASE OF A BATCH PROBLEM. THE HOSPITAL STAFF RECEIVED FURTHER TRAINING ON
`EXPOSURE AND SAFE LEVELS OF NO/NO2 IN THE ATMOSPHERE AND CYLINDER MANAGEMENT." THE VENDOR CONFIRMED THE O‐RING WAS
`DAMAGED. THE INOVENT OPERATION & MAINTENANCE MANUAL INDICATES THE CORRECT PROCEDURE TO CONNECT AN NO CYLINDER TO AN
`INOVENT; HOW TO CHECK FOR LEAKS; AND THE APPROPRIATE ACTION TO TAKE IF A LEAK IS DETECTED.
`
`Page 1 of 53
`
`Ex. 2035-0001
`
`
`
`Web Address
`
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=766265
`
`Report
`Number
`2112667‐
`2006‐
`00055
`
`Manufactu
`rer
`
`GE
`HEATHCAR
`E
`
`Brand Name
`
`INOVENT
`
` Product
`Date Report
`Code
`Received
`9/29/2006 MRN
`
`Event Date
`
`Event Type
`
`4/1/2006 Injury
`
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=744085
`
`2112667‐
`2006‐
`00029
`
`GE
`HEALTHCA
`RE
`
`INOVENT
`
`8/3/2006 MRN
`
`6/17/2006 Death
`
`Event Text
`
` Event Description: ACCORDING THE SUSPECT ADVERSE EVENT REACTION REPORT RECEIVED FROM INOT; "A NURSE WAS CHANGING OVER AN EMPTY
`INOMAX CYLINDER FOR A NEW ONE WHILE ON A PATIENT. ANOTHER STAFF MEMBER WAS READING THE INSTRUCTIONS. ON TURNING THE NEW
`CYLINDER ON; IT SOUNDED LIKE A HISS WHICH WAS THOUGHT TO BE A LOW LEVEL LEAK. THE NURSE WAS ABOUT TO INVESTIGATE FURTHER WHEN A
`TORRENTIAL LEAK OCCURRED WITH A REPORTED PROMINENT SMELL OF NITRIC OXIDE GAS. THE CYLINDER WAS TURNED OFF AND THE NURSE LEFT
`THE ROOM. ABOUT ONE HOUR AFTER THE INCIDENT; THE NURSE WAS SEEN IN A&E DEPT. FOR COMPLAINTS OF TIGHTENING IN THE CHEST AND PAIN
`SIMILAR TO BRONCHITIS. HE RECEIVED TREATMENT WITH O2 AND WAS HOSPITALIZED OVERNIGHT. THE OTHER TWO STAFF MEMBERS PRESENT
`DURING THE EVENT ALSO DEVELOPED CHEST TIGHTNESS AND WERE ATTENDED TO IN THE A&E DEPT. BUT RETURNED STRAIGHT TO DUTY WITH NO
`FURTHER SIDE EFFECTS. FOLLOWING DISCHARGE IN 2006; THE NURSE HAS DEVELOPED FOUR EPISODES OF SUDDEN CHEST TIGHTENING AND
`DIFFICULTY BREATHING. DURING A FOLLOW‐UP VISIT AT THE HOSPITAL; THE DOCTOR THOUGHT THE EVENTS MIGHT CONTINUE FOR THE NEXT 3
`WEEKS DUE TO AN INHALATION INJURY. THE NURSE HAS REPORTED BREATHING DIFFICULTIES ONCE PER WEEK AT THE TIME OF THE REPORT WITH
`HOPE THAT THEY WILL RESOLVE COMPLETELY." THE SUSPECT ADVERSE EVENT REACTION REPORT STATES THE EVENT INVOLVED A NURSE AND TWO
`STAFF MEMBERS. THIS MEDWATCH REPORT WILL REPRESENT THE NURSE INVOLVED IN THE ALLEGED EVENT. Manufacturer Narrative:
`INVESTIGATION/CONCLUSION: NO PARTS WERE RETURNED TO GE HEALTHCARE FOR INVESTIGATION. ACCORDING TO THE SUSPECT ADVERSE EVENT
`REACTION REPORT; "THE FAULT SEEMS TO BE THE RUBBER O‐RING ON THE TIP OF THE HIGH PRESSURE ASSEMBLY; CAUSING A BAD PRESSURE SEAL
`PER THE HOSPITAL REPORTER. THE INOVENT; CYLINDER; AND O‐RING CONCERNED WERE REMOVED FROM THE HOSPITAL FOR INVESTIGATION. ALL O‐
`RINGS PREVIOUSLY SENT TO THE HOSPITAL WERE REPLACED IN CASE OF A BATCH PROBLEM. THE HOSPITAL STAFF RECEIVED FURTHER TRAINING ON
`EXPOSURE AND SAFE LEVELS OF NO/NO2 IN THE ATMOSPHERE AND CYLINDER MANAGEMENT." THE DISTRIBUTOR RETURNED THE O‐RING TO THE
`VENDOR FOR INVESTIGATION. THE VENDOR CONFIRMED THE O‐RING WAS DAMAGED. THE INOVENT OPERATION & MAINTENANCE MANUAL
`INDICATES THE CORRECT PROCEDURE TO CONNECT AN NO CYLINDER TO AN INOVENT; HOW TO CHECK FOR LEAKS; AND THE APPROPRIATE ACTION
`TO TAKE IF A LEAK IS DETECTED.
`
` Event Description: PER MEDWATCH REPORT SUBMITTED BY DISTRIBUTOR; A PATIENT WAS BEING TREATED WITH INOMAX. THE CYLINDER WAS
`REPORTEDLY LEAKING AND HAD TO BE CHANGED. IN ATTEMPTING TO CHANGE THE INOMAX CYLINDER; IT WAS REPORTEDLY NOTED THAT THE KEL F
`TIP WAS MISSING FROM THE SECOND REGULATOR AND A NEW CYLINDER COULD NOT BE CONNECTED. A SECOND INOVENT UNIT WAS BROUGHT TO
`THE BEDSIDE. THERAPY WAS STOPPED WHILE THE INOVENT WAS REPLACED. DURING THIS TIME; THE PATIENT'S HEART RATE; OXYGEN SATURATION;
`AND BLOOD PRESSURE REPORTEDLY DECREASED. THE STAFF REPORTEDLY DID NOT USE THE MANUAL BACK UP SYSTEM TO MAINTAIN THE FLOW OF
`INOMAX TO THE PATIENT. ONCE THERAPY WAS RESTARTED; THE PATIENT'S VITAL SIGNS RECOVERED. WHEN THE REGULATOR WAS REMOVED FROM
`THE EMPTY CYLINDER; THE KEL F TIP REPORTEDLY REMAINED IN THE VALVE. THE PATIENT REPORTEDLY DIED 4 DAYS LATER. ACCORDING TO
`DISTRIBUTOR; THE DEATH WAS REPORTEDLY NOT RELATED TO THE INTERRUPTED THERAPY TO THE PATIENT. Manufacturer Narrative:
`INVESTIGATION/CONCLUSION: SAMPLES WERE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE KEL‐F TIP USED DURING THE ALLEGED
`EVENT WAS VISUALLY INSPECTED AND WAS NOTED TO BE IN GOOD CONDITION WITH A MINOR SCRATCH ON THE SEALING FACE. THE 'LEGS' OF THE
`SEAL WERE SLIGHTLY DAMAGED; AND THE DAMAGE APPEARS TO BE DUE TO THE INTERNAL THREADS CUTTING INTO THEM WHEN IT WAS REMOVED
`FROM THE FITTING. THE TIP WAS REASSEMBLED TO ONE OF THE REGULATOR ASSEMBLIES ON THE CART AND THEN LEAK TESTED. NO LEAKS WERE
`OBSERVED. A TORQUE TEST WAS SUBSEQUENTLY PERFORMED ON THE FITTING TO VERIFY IF IT WAS POSSIBLE FOR THE KEL‐F TIP TO BECOME
`DISLODGED AND JAM IN THE CYLINDER CONNECTOR AS REPORTED. TESTING DID NOT DISLODGE THE KEL‐F TIP. HOWEVER; USING A LARGE WRENCH
`ON THE FLATS OF THE HAND WHEEL AND APPLYING AN EXTREME TORQUE; IT WAS POSSIBLE TO JAM THE TIP IN THE CYLINDER CONNECTOR AND
`DISLODGE THE TIP FROM THE END OF THE FITTING AS REPORTED. THE INOVENT OPERATION AND MAINTENACE MANUAL WARNS THE USER TO VERIFY
`THAT THE HOSE TIP IS IN PLACE AND IS NOT DAMAGED BEFORE CONNECTING TO THE CYLINDER; AND NOT TO OVER‐TIGHTEN THE FITTING. THE
`MANUAL ALSO INSTRUCTS THE USER TO FOLLOW THE PRE‐USE PROCEDURE BEFORE THE START OF EACH PATIENT; AND TO PERFORM A HIGH‐
`PRESSURE LEAK TEST AT LEAST ONCE A MONTH.
`
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=779466
`
`2112667‐
`2006‐
`00075
`
`DATEX‐
`OHMEDA
`
`INOVENT
`
`11/2/2006 MRN
`
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=809142
`
`2112667‐
`2007‐
`00002
`
`DATEX‐
`OHMEDA
`
`INOVENT
`
`1/16/2007 MRN
`
`9/10/2006 Other
`
` Event Description: ACCORDING TO THE DISTRIBUTOR; IT WAS NOTED AT THE FACILITY THAT A PATIENT WAS BEING ADMINISTERED NITRIC OXIDE VIA
`A FLOWMETER ON THE WALL; WHILE SPONTANEOUSLY BREATHING INTO A FACE MASK THAT ENTIRELY COVERED THE PATIENT'S HEAD. THE INOVENT
`WAS SET AT 40PPM. ACCORDING TO THE DISTRIBUTOR; THE CUSTOMER IS USING THE DEVICE IN AN UNAPPROVED MANNER. THE DISTRIBUTOR
`INFORMED THE CUSTOMER OF THE IMPROPER USAGE OF THE DEVICE; HOWEVER; THE CUSTOMER CHOSE TO CONTINUE USE IN THE UNAPPROVED
`MANNER. PROPER SETUP OF THE UNIT IS DESCRIBED IN THE INOVENT OPERATION AND MAINTENANCE MANUAL; AND A DIAGRAM DEPICTING
`PROPER SETUP IS AFFIXED TO THE SIDE OF THE INOVENT. Manufacturer Narrative: H6: CUSTOMER IS USING THE DEVICE IN AN UNAPPROVED
`MANNER.
`12/13/2006 Malfunction Event Description: CUSTOMER REPORTED THE UNIT HAD AN O‐RING FAILURE. PATIENT REPORTEDLY DESATURATED. HOSP STAFF SWITCHED TO THE
`BACKUP SYSTEM AND STARTED MANUAL VENTILATION WITH NITRIC OXIDE. HOSP STAFF REPORTEDLY HEARD A LEAK; AND THE UNIT WAS
`EXCHANGED. SOME OF THE STAFF IN THE ROOM REPORTEDLY BECAME DIZZY FROM THE SMELL OF NITRIC OXIDE. THERE WAS NO REPORTED INJURY
`WITH PATIENT OR STAFF. INVESTIGATION/CONCLUSION: NO PARTS WERE RETURNED TO GE HEALTHCARE FOR INVESTIGATION AS THE CUSTOMER
`REPORTEDLY DISCARDED THE O‐RING. WITHOUT THE SAMPLE FOR INVESTIGATION; THE MANUFACTURER AND/OR EXACT ROOT CAUSE OF THE
`REPORTED COMPLAINT CANNOT BE DETERMINED. THE REPORTER'S MAINTENANCE MANUAL INDICATES THE CORRECT PROCEDURE TO CONNECT AN
`NO CYLINDER; HOW TO CHECK FOR LEAKS; AND THE APPROPRIATE ACTION TO TAKE IF A LEAK IS DETECTED. Manufacturer Narrative: NO PARTS WERE
`RETURNED TO GE HEALTHCARE FOR INVESTIGATION AS THE CUSTOMER REPORTEDLY DISCARDED THE O‐RING. WITHOUT THE SAMPLE FOR
`INVESTIGATION; THE MANUFACTURER AND/OR EXACT ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED.
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=832241
`
`832241 PULMONO
`X MEDICAL
`INC
`
`AERONOX
`
`3/7/2007 MRN
`
`2/13/2007 Malfunction Event Description: READINGS FLUCTUATING ON DISPLAY 0‐70; DISPLAY THEN READS 666666 PER TRANSPORT NURSE.
`
`Page 2 of 53
`
`Ex. 2035-0002
`
`
`
`Web Address
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=981925
`
`Report
`Number
`2112667‐
`2008‐
`00003
`
`Manufactu
`rer
`DATEX‐
`OHMEDA
`
`Brand Name
`
`INOVENT
`
` Product
`Date Report
`Code
`Received
`1/22/2008 MRN
`
`Event Date
`
`Event Type
`
`12/21/2007 Death
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=989023
`
`2112667‐
`2008‐
`00006
`
`DATEX‐
`OHMEDA
`
`INOVENT
`
`1/31/2008 MRN
`
`12/28/2007 Malfunction
`
`Event Text
`
` Event Description: PER MEDWATCH REPORT FROM IKARIA: "A FEMALE INFANT WAS BORN IN 2007 WITH A WEIGHT OF 3.6 KILOGRAMS. SHE WAS
`DELIVERED VIA CESAREAN SECTION DUE TO FETAL DISTRESS. SHE REQUIRED TRANSFER TO ANOTHER FACILITY FOR AORTIC ARCH RECONSTRUCTION
`AND A NORWOOD PROCEDURE. ON SEVENTEEN DAYS LATER; THE INFANT WAS DISCONTINUED FROM EXTRA CORPOREAL MEMBRANE OXYGENATION
`(ECMO) AND PLACED ON INOMAX AT 20 PARTS PER MILLION FOR THE TREATMENT OF PULMONARY HYPERTENSION. ON THE NEXT DAY; THE GAS
`OUTLET LINE FROM THE JET VENTILATOR BECAME DISCONNECTED. THE INFANT DEVELOPED BRACHYCARDIA. INOVENT HAD A HIGH NITRIC OXIDE
`LEVEL ALARM (OVER 24 PARTS PER MILLION AND RISING) AND WAS PLACED ON MANUAL STANDBY. HER SPO2 WAS BELOW 60%; HEART RATE AND
`BLOOD PRESSURE DECREASED. SHE WAS HAND BAGGED WITH INOMAX AND 100% OXYGEN. THE STAFF FOUND THE TUBING LEADING TO THE
`INJECTOR MODULE SATURATED WITH WATER. THE STAFF DID A LOW RANGE PURGE OF THE LINE AND A CALIBRATION. THE INFANT EXPERIENCED
`HYPOTENSION RESULTING IN CARDIOPULMONARY ARREST. RESUSCITATION EFFORTS WERE UNSUCCESSFUL. THE INFANT EXPIRED ON THE SAME
`DAY." GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW‐UP REPORT WILL BE ISSUED WHEN THE
`INVESTIGATION HAS BEEN COMPLETED.
`
` Event Description: A FEMALE INFANT WAS HOSPITALIZED. SHE WAS RECEIVING INOTHERAPY FOR SEVEN DAYS AND WAS NOT EXPECTED TO SURVIVE.
`IN 2007 INOVENT EXPERIENCED AN ELECTRONIC FAILURE WHILE ON THE INFANT. FOLLOWING TH INOVENT MACHINE FAILURE; THE INFANT WAS
`MANUALLY BAGGED WHILE THE INOVENT WAS INITIALLY RE‐STARTED AND THEN REPLACED WITH A BACK‐UP INOVENT. IT WAS NOTED THAT THE
`INFANT EXPERIENCED AN EPISODE OF BRADYCARDIA DURING THIS PERIOD. THE INFANT SUBSEQUENTLY EXPIRED THE FOLLOWING DAY WHICH WAS
`EXPECTED; BUT MAY OR MAY NOT HAVE BEEN HASTENED BY THE EVENT. THE REPORTER DEEMED THE EVENT POSSIBLY RELATED AS THE PT'S
`CONDITION CHANGED DUE TO THE BRADYCARDIA." GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U
`REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=981940
`
`2112667‐
`2008‐
`00004
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=1178783
`
`2112667‐
`2008‐
`00011
`
`DATEX‐
`OHMEDA
`
`INOVENT
`
`1/22/2008 MRN
`
`DATEX‐
`OHMEDA
`
`INOVENT
`
`3/11/2008 MRN
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=1327623
`
`1327623 IKARIA
`
`INOVENT
`
`12/23/2008 MRN
`
`12/31/2007 Death
`
` Event Description: ACCORDING TO THE DISTRIBUTOR; PT WAS HOSPITALIZED AWAITING A LUNG TRANSPLANT. PT WAS REPORTEDLY PLACED ON
`INOMAX AT 20 PPM FOR THE TREATMENT OF PULMONARY HYPERTENSION. THE UNIT REPORTEDLY HAD A FAILURE MESSAGE. THE NURSE
`REPORTEDLY HAND BAGGED THE PT DUE TO A SIGNIFICANT DECREASE IN OXYGEN SATURATION. HER PULMONARY ARTERY PRESSURE WAS 90/39.
`THE PT REPORTEDLY DIED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW‐UP REPORT WILL BE
`ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
`2/1/2008 Malfunction Event Description: ACCORDING TO DISTRIBUTOR FILED MEDWATCH REPORT; "A (B) (6) FEMALE; STATUS POST LUNG TRANSPLANT; RECEIVED
`INOMAX AT 20 PPM ON (B) (6); 2008 FOR THE OFF‐LABELED INDICATION OF SEVERE HYPOXEMIA. AT THE START OF INOMAX TREATMENT THE
`PATIENT'S OXYGEN SATURATION WAS 87%. THE INOVENT ((B) (6)) ALARMED AND THE ERROR "ELECTRONIC DELIVERY SHUTDOWN" DISPLAYED AND
`THE PATIENT'S OXYGEN SATURATION DECREASED INTO THE 70'S. THE PATENT ARRESTED AND WAS RESUSCITATED USING INOVENT FLOW
`METER/MANUAL VENTILATION AND THE PATIENT'S PULSE RETURNED AFTER CHEST COMPRESSIONS WERE INITIATED. THE PATIENT WAS PUT ON A
`NEW INOVENT AND THE PATIENT'S OXYGEN SATURATION RETURNED TO BASELINE (89%). INOMAX THERAPY WAS DISCONTINUED LATER THAT SAME
`DAY." GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW‐UP REPORT WILL BE ISSUED WHEN THE
`INVESTIGATION HAS BEEN COMPLETED.
` Event Description: PT ON VENTILATOR IN ICU AT THIS HOSPITAL HAD ORDER TO INITIATE INOTHERAPY IN 2008. EQUIPMENT BROUGHT TO HOSPITAL
`FROM MANUFACTURER; SETUP AND INSERVICING OF STAFF DONE; DELIVERY OF NITRIC OXIDE WAS TO BE 60 PPM. THE NEXT DAY; ALARM SOUNDED
`FOR LOW TO NO DELIVERY OF NITRIC OXIDE AS PPM'S FELL BELOW SET PARAMETER. PT MANUALLY BAGGED WHICH DELIVERS 20 PPM. THREE BRIEF
`EPISODES OF THIS OCCURRED; WITH PATIENT'S O2 SATURATION DROPPING INTO 60'S EACH TIME. MANUFACTURER CONTACTED AND NEW
`EQUIPMENT DELIVERED. PT EXPIRED THE FOLLOWING DAY OF HER UNDERLYING DISEASE UNRELATED TO THIS EVENT.
`
`2/4/2008 Injury
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=1066287
`
`2112667‐
`2008‐
`00023
`
`DATEX‐
`OHMEDA
`
`INOVENT
`
`6/26/2008 MRN
`
`4/29/2008 Injury
`
` Event Description: PER ADVERSE EVENT REPORT SUBMITTED BY DISTRIBUTOR; "A FEMALE WITH A HISTORY OF HIGH PEAK PRESSURE ON
`MECHANICAL VENTILATION AND DIFFICULTY WITH GAS EXCHANGE WAS HOSPITALIZED. IN 2008; SHE BEGAN 10 PARTS PER MILLION (PPM) OF INO
`THERAPY FOR PULMONARY HYPERTENSION. ON A WEEK LATER 01:50 HOURS; THE GRAPHIC USER PANEL OF INOVENT FLASHED "ELECTRONIC
`DELIVERY FAILURE" ON THE SCREEN THEN CHANGED TO A SCREEN WITH TWO ICONS. THE MACHINE THEN ALARMED AND CEASED DELIVERY OF
`NITRIC OXIDE TO THE PT. WHEN THE DEVICE BECAME INOPERATIVE; THE PT EXPERIENCED IMPAIRED OXYGENATION AND INCREASED BAROTRAUMA.
`THE OUTCOMES OF THE EVENTS ARE NOT KNOWN. THE REPORT DEEMED THE EVENTS RELATED TO THE USE OF INOTHERAPY. LAB TESTS UNK." GE
`HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW‐UP REPORT WILL BE ISSUED WHEN THE
`INVESTIGATION HAS BEEN COMPLETED.
`
`Page 3 of 53
`
`Ex. 2035-0003
`
`
`
`Web Address
`
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=1080074
`
`Report
`Number
`300453158
`8‐2008‐
`00002
`
`Manufactu
`rer
`INO
`THERAPEU
`TICS
`LLC/IKARIA
`
`Brand Name
`
`INOMAX DS (DELIVERY
`SYSTEM)
`
` Product
`Date Report
`Code
`Received
`7/15/2008 MRN
`
`Event Date
`
`Event Type
`
`5/30/2008 Other
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=1067184
`
`1067184 IKARIA
`
`INOMAX DS
`
`6/19/2008 MRN
`
`5/30/2008 NA
`
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=1220574
`
`2112667‐
`2008‐
`00046
`
`DATEX‐
`OHMEDA
`
`INOVENT
`
`11/3/2008 MRN
`
`10/22/2008 Death
`
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=1456028
`
`2112667‐
`2009‐
`00025
`
`DATEX‐
`OHMEDA
`
`INOVENT
`
`4/28/2009 MRN
`
`1/14/2009 Death
`
`Event Text
`
` Event Description: ON (B) (6) 2008; AN ADVERSE EVENT WAS REPORTED VIA A HEALTH CARE PROFESSIONAL. THE ADVERSE EVENT OCCURRED WHEN
`A HEALTH CARE PROFESSIONAL ENGAGED THE INOMAX DS BACK UP SWITCH WHILE 20 PARTS PER MILLION (PPM) OF INHALED NITRIC OXIDE (INO)
`WAS STILL BEING DELIVERED TO THE PT VIA INOMAX DS (B) (4). THE INO EXCEEDED 100 PPM AND AS DESIGNED; ALARMED AND CEASED DRUG
`DELIVERY. THE BACKUP SWITCH WAS TURNED ON IN A MISTAKEN ATTEMPT TO TURN ON FLOW FOR MANUAL BAGGING AND THE ALARMS THAT
`IMMEDIATELY OCCURRED WERE IGNORED OR MISUNDERSTOOD. AT THE TIME; THERE WAS A LARGE SIGN ATTACHED TO THE FRONT OF THE INOMAX
`DS DEVICE EXPLAINING HOW TO TURN ON THE GAS FLOW FOR MANUAL VENTILATION. BUT IT WAS NOT OPTIMALLY POSITIONED AND WAS
`OVERLOOKED. THE REPORTER INDICATED THAT EARLIER THE SAME DAY; THE HEALTH CARE PROFESSIONAL INVOLVED IN THE INCIDENT WAS ASKED
`BY THE RESPIRATORY THERAPIST IF THEY KNEW HOW TO TURN ON THE FLOW FOR MANUAL VENTILATION. THE HEALTH CARE PROFESSIONAL
`INDICATED AN UNDERSTANDING OF THE PROCEDURE. DURING THE EVENT; A THERAPIST WAS PAGED AND THE SITUATION WAS CORRECTED. IT WAS
`REPORTED THE EVENT OCCURRED DUE TO HUMAN ERROR; INCOMPLETE EDUCATION; AND INADEQUATE POSITIONING OF THE SIGNAGE BY THE
`FACILITY. FOLLOWING THIS EVENT; ADDITIONAL EDUCATIONAL SESSIONS WERE CONDUCTED; THE SIGNAGE POSITIONING WAS MODIFIED BY THE
`FACILITY; AND THE BACKUP SWITCH WAS INACTIVATED BY USING A THIN RIBBON OF REINFORCED STRAPPING TAPE. THE REPORTER DID NOT THINK
`THE EVENT WAS SERIOUS. FOLLOW UP INFO WAS RECEIVED ON JUNE 27; 2008; VIA A MEDWATCH REPORT RECEIVED FROM THE FDA THAT WAS
`SUBMITTED BY THE HOSPITAL. THE PT IS A (B) (6); (B) (6) FEMALE WITH A WEIGHT OF (B) (6). SHE WAS BORN PREMATURE AND HAS A HISTORY OF
`CHRONIC LUNG DISEASE AND PULMONARY HYPERTENSION. ON (B) (6) 2008; THE PT HAD A SUDDEN DESATURATION (VALVES NOT REPORTED) DUE
`TO THE ENDOTRACHEAL TUBE BEING UNPLUGGED. WHEN THE NURSE ATTEMPTED TO USE THE BAG VALVE MASK (BVM) FROM THE SYSTEM; IT
`WOULD NOT INFLATE. THE RESPIRATORY THERAPIST WAS CALLED IMMEDIATELY. THE NURSE TURNED ON THE INOMAX DS BACKUP SWITCH IN AN
`ATTEMPT TO TROUBLESHOOT THE PROBLEM; APPLIED 100% OXYGEN BAG VALVE MASK (BVM); AND THEN CORRECTED THE SYSTEM. THE NITRIC
`OXIDE DELIVERY SYSTEM'S SWITCH DISPLAYED A SIGN SAYING; "DO NOT TURN ON". ADDITIONAL INFO ATTACHED TO THE SYSTEM DESCRIBED HOW
`TO TURN ON THE GAS FLOW MANUALLY; AS DID EDUCATION POSTERS DISPLACED IN THE INTENSIVE CARE UNIT (ICU). THE RESPIRATORY THERAPIST
`SAID THEY WERE GOING TO CHECK WITH THE NURSE INVOLVED TO SEE IF SHE KNEW HOW TO VENTILATE THE PT MANUALLY. THE NURSE REPLIED
`YES; BUT SHE OBVIOUSLY DID NOT FULLY UNDERSTAND THE PROCEDURE IN THIS PARTICULAR CASE. THIS WAS AN EXAMPLE OF AN OPERATOR ISSUE
`ERROR AND NOT A MACHINE ISSUE. Manufacturer Narrative: USE ERROR REPORTED BY USER FOLLOWING THEIR INVESTIGATION AND (B) (6) FOLLOW
`UP. THEREFORE THE INOMAX DS WAS NOT RETURNED FOR EVAL.
`
` Event Description: THE INOMAX DS HAS A BACKUP SWITCH THAT IS EASILY ACTIVATED OR INACTIVATED. THE PATIENT HAD A SUDDEN
`DESATURATION DUE TO THE ENDOTRACHEAL TUBE BEING PLUGGED. WHEN THE NURSE ATTEMPTED TO USE THE BVM FROM THE SYSTEM; IT WOULD
`NOT INFLATE; SO RESPIRATORY THERAPY WAS CALLED IMMEDIATELY. THE NURSE TURNED ON THE BACKUP SWITCH IN AN ATTEMPT TO
`TROUBLESHOOT THE PROBLEM; HOWEVER; THE PATIENT CONTINUED TO DECOMPENSATE. AT THIS TIME; THE RESPIRATORY THERAPIST ENTERED THE
`ROOM AND APPLIED 100% O2 BVM; AND THEN CORRECTED THE SYSTEM. THE NITRIC OXIDE DELIVERY SYSTEM'S SWITCH DISPLAYED A SIGN SAYING:
`DO NOT TURN ON. ADDITIONAL INFORMATION ATTACHED TO SYSTEM DESCRIBED HOW TO TURN ON THE GAS FLOW MANUALLY; AS DID EDUCATION
`POSTERS DISPLAYED IN ICU. THE RESPIRATORY THERAPIST SAID THEY WERE GOING TO CHECK WITH THE NURSE INVOLVED TO SEE IF SHE KNEW HOW
`TO VENTILATE THE PATIENT MANUALLY. THE NURSE REPLIED YES; BUT SHE OBVIOUSLY DID NOT FULLY UNDERSTAND THE PROCEDURE IN THIS
`PARTICULAR CASE. THIS WAS AN EXAMPLE OF AN OPERATOR ISSUE ERROR AND NOT A MACHINE ISSUE.
`
` Event Description: PER REPORT FROM DISTRIBUTOR: "PATIENT CARE BEING DONE ON BABY ‐ BABY WAS TURNED ‐ JET VENTILATOR PUT INTO STAND‐
`BY MODE. HIGH NO ALARMED. INOVENT WORKED AS INTENDED WHEN 100 PPM REACHED. BABY MANUALLY RESUSCITATED. INOVENT REPLACED.
`RECALIBRATED NEW INOVENT IN 15 MINUTES. PATIENT BACK ON INOVENT; BUT NEVER FULLY RECOVERED. SHUT DOWN OCCURRED 4 TO 5 HOURS
`PRIOR TO PATIENT DEATH. AFTER INOVENT SHUT DOWN; BABY DECOMPENSATED AND HR INCREASED; AND WAS MANUALLY RESUSCITATED.
`PATIENT'S STATUS DETERIORATED AND NEVER RETURNED TO PREVIOUS STATUS. APPROXIMATELY 2 HOURS LATER; BOWEL PERFORATION FIRST
`NOTICED. PATIENT HAD SURGERY FOR BOWEL PERFORATION; BUT PATIENT'S STATUS NEVER CAME BACK TO BASELINE. PATIENT WENT INTO DIC AND
`DID NOT RECOVER." GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW‐UP REPORT WILL BE ISSUED
`WHEN THE INVESTIGATION HAS BEEN COMPLETED. Manufacturer Narrative: .
`
` Event Description: PER DISTRIBUTOR MEDWATCH REPORT: "AN ADULT MALE RECEIVED 20 PPM OF INHALED NITRIC OXIDE FOR THE TREATMENT OF
`PULMONARY HYPERTENSION. IN EARLY 2009; AT 02:30; INOVENT UNIT CCAD00655 ALARMED AND HAD AN ELECTRONIC SHUT DOWN WHILE ON THE
`PATIENT IN THE OPERATING ROOM. THE PATIENT DECOMPENSATED; HIS OXYGEN SATURATION DECREASED IN THE 60S; AND HIS HEART RATE
`DECREASED TO 40 BPM. THE ANESTHESIA DID NOT MANUALLY BAG THE PATIENT AND THE EVENTS RESOLVED AFTER THE INOVENT UNIT WAS
`SWITCHED OUT; AND THE PATIENT CONTINUED TREATMENT. THE REPORTER DEEMED THE EVENTS RELATED TO THE INOVENT FAILURE. APPROX. TWO
`WEEKS LATER; THE PATIENT EXPIRED FROM AN UNKNOWN CAUSE OF DEATH; AND IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED." GE
`HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW‐UP REPORT WILL BE ISSUED WHEN THE
`INVESTIGATION HAS BEEN COMPLETED. Manufacturer Narrative: .
`
`Page 4 of 53
`
`Ex. 2035-0004
`
`
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=1394996
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=1543768
`
`1394996 GE
`MEDICAL
`SYSTEMS;
`LLC
`DATEX‐
`OHMEDA
`
`2112667‐
`2009‐
`00060
`
`REUSEABLE CO2
`ABSORBENT CANISTER
`
`11/20/2009 MRN
`
`9/23/2009 Injury
`
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=1523317
`
`2112667‐
`2009‐
`00056
`
`DATEX‐
`OHMEDA
`
`INOVENT (DELIVERY
`SYSTEM)
`
`11/4/2009 MRN
`
`10/1/2009 Injury
`
`Web Address
`
`
`http://www.accessdata.fda.gov/script
`s/cdrh/cfdocs/cfMAUDE/detail.cfm?
`mdrfoi__id=1369217
`
`Manufactu
`Report
`rer
`Number
`1369217 IKARIA INO
`THERAPEU
`TICS INC
`
`Brand Name
`
`DATEX‐OHMEDA
`INOVENT SYSTEM
`
` Product
`Date Report
`Code
`Received
`4/9/2009 MRN
`
`Event Date
`
`Event Type
`
`1/14/2009 Death
`
`Event Text
`
` Event Description: PT HAD A DIAGNOSIS OF IPF AND ACUTE RESPIRATORY FAILURE. WAS MAINTAINED IN THE ICU INTUBATED; SEDATED AND FULLY
`SUPPORTED ON A VENTILATOR RECEIVING INHALED NITRIC OXIDE THRU AN INO VENT DELIVERY DEVICE. PT WAS TRANSPORTED FROM ICU TO OR
`FOR RT. LUNG TRANSPLANT WITHOUT INCIDENT. WHILE PT WAS WAS IN OR RECEIVING NITRIC OXIDE THRU THE INOVENT AND PRIOR TO SURGERY;
`THERE WAS A FAILURE OF THE INOVENT MACHINE. THE PT SUFFERED AN ARREST; CPR WAS INITIATED; PT GIVEN EPINEPHRINE; AND REGAINED HIS
`BLOOD PRESSURE. THE INOVENT MACHINE WAS CHANGED OUT FOR ANOTHER MACHINE. THE PT WAS EMERGENTLY PLACED ON BYPASS AND THE
`SURGERY PROCEEDED. POST‐OP THE PT WAS SENT BACK TO ICU;UNDERWENT 2 ADDITIONAL SURGERIES; A MEDIASTINAL EXPLORATION AND
`WASHOUT THE NEXT DAY AND DECANNULATION FROM EXTRACORPOREAL LIFE SUPPORT/REMOVAL OF EXTRACORPOREAL VENTRICULAR ASSIST
`DEVICE THREE DAYS AFTER EVENT OCCURRED. PT HAD DETERIORATING NEUROLOGICAL STATUS AND WEEKS LATER HAD BRAIN CT. SHOWED
`MULTIPLE FOCI OF HEMORRHAGE IN THE RT PARIETAL AND RT FRONTAL LOBES AS WELL AS SUBARACHNOID HEMORRHAGE IN LEFT FRONTAL AND
`LEFT PARIETAL LOBES. ALSO A SMALL INTRAVENTRICULAR HEMORRHAGE WAS NOTED. PT'S SURGEON AND PT FAMILY OPTED TO WITHDRAW CARE
`AND PT EXPIRED.====================== MANUFACTURER RESPONSE FOR NITRIC OXIDE GAS & DELIVERY SYSTEM; DATEX‐
`OHMEDA======================WILL EVALUATE DEVICE.
`
`INOVENT DELIVERY
`SYSTEM
`
`5/15/2009 MRN
`
`3/13/2009 Malfunction Event Description: LOUD BANG AND SPARKS COMING FROM INOVENT WHICH WAS BEING USED IN THE OR VIA VENTILATOR CIRCUIT.
`
` Event Description: A CUSTOMER ALLEGES THAT A HOSPITAL TECHNICIAN INJURED HER WRIST WHILE FILLING A MEDISORB; REUSEABLE CO2
`ABSORBENT CANISTER. THE PROCESS OF FILLING THE CANISTER INVOLVES TWISTING OFF THE LID TO REFILL AND THEN CLOSING THE LID AND
`LOCKING IT. THE EXTENT OF THE INJURY COULD NOT BE DETERMINED; HOWEVER; THE EMPLOYEE'S WRIST HAS BEEN SPLINTED. THE TECHNICIAN IS
`REPORTEDLY OF SMALL BUILD AND HAS DIFFICULTY COMPLETING THE TASK OF FILLING THE CANISTER DUE TO THE SMALL SIZE OF HER HANDS. THE
`ALLEGATION OF INJURY IS NOT DUE TO A MALFUNCTION OF A SPECIFIC CANISTER OR LOT# BUT RATHER TO THE DESIGN OF THE PRODUCT IN
`GENERAL. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW‐UP REPORT WILL BE ISSUED WHEN
`THE INVESTIGATION HAS BEEN COMPLETED.
` Event Description: A MALE BORN IN 2003; HAS A HISTORY OF HEMORRHAGIC ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) AND BONE
`MARROW TRANSPLANT. HE RECEIVED 40 PARTS PER MILLION (PPM) OF CONTINUOUS INHALED NITRIC OXIDE FOR THE TREATMENT OF ARDS. THE PT
`WAS ON A 3100A SENSORMEDICS VENTILATOR IN A HIGH FREQUENCY OSCILLATORY VENTILATION (HFOV) UNFILTERED PT CIRCUIT WITH THE
`FOLLOWING SETTINGS: RESPIRATORY RATE 7 HERTZ; HFOV MODE; AND TOTAL FLOW RATE 25‐30 LITERS/MINUTE. IN 2009; A RESPIRATORY THERAPIST
`ATTEMPTED TO PERFORM A LOW CALIBRATION ON INOVENT MACHINE; WHILE ON THE PT. THE INOVENT MACHINE WAS RUNNING IN NORMAL
`OPERATION MODE AT 40 PPM AND NO SUCTIONING OR NURSING CARE WAS BEING PERFORMED AT THIS TIME. THE LOW CALIBRATION FAILED AND
`THE RESPIRATORY THERAPIST PROCEEDED TO PERFORM A HIGH CALIBRATION. FOLLOWING HIGH CALIBRATION WHICH LASTED APPROXIMATELY 1
`MINUTE; MONITORED NITRIC OXIDE (NO) BEGAN TO RISE. WHEN NO MEASURED REACHED 100 PPM; THE HIGH NO ALARMED AND THE INOVENT
`WENT INTO ELECTRONIC SHUTDOWN. AFTER INOVENT SHUTDOWN; THE PT'S OXYGEN SATURATION DECREASED FROM 88% TO APPROX 77%. HE WAS
`MANUALLY BAGGED BY THE RESPIRATORY THERAPIST WITH 80 PPM NO AND THE PT'S OXYGEN SATURATION RESOLVED TO PREVIOUS LEVEL OF
`OXYGEN SATURATION IN APPROXIMATELY 10 MINUTES. THE INOVENT MACHINE WAS REPLACED AND NO DELIVERY CONTINUED. THE PT WAS
`MANUALLY BAGGED FOR ABOUT 1 HOUR. THE RESPIRATORY THERAPIST DEEMED THE OXYGEN SATURATION DECREASE TO BE RELATED TO THE
`INOVENT SHUTDOWN. Manufacturer Narrative: THE DEVICE INVESTIGATION RESULTS ARE AS FOLLOWS: THE ERROR LOGS INDICATED MULTIPLE
`INSTANCES OF LOW RANGE CALIBRATION FAILURE DUE TO THE NO SENSOR WHILE IN USE. THE ERROR LOGS CONFIRMED A SYSTEM SHUTDOWN
`OCCURRED DUE TO THE DEVICE MONITORING 100 PPM NO. INOVENT WAS RETURNED MISSING THE INJECTOR MODULE THAT WAS IN USE AT THE
`TIME OF THE REPORTED INCIDENT. THE INOVENT ELECTRONIC DELIVERY SYSTEM WILL NOT FUNCTION WITHOUT AN INJECTOR MODULE. A NEW
`INJECTOR MODULE WAS USED IN ORDER TO TEST THE DEVICE. THE DEVICE MONITORED 9PPM NO ON ROOM AIR AFTER INITIAL BO