BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN ONE OXYGEN CONCENTRATOR

    MDR report key: 940589 · Received November 11, 2007

    Report

    Report Number
    3004672275-2007-00002
    Event Type
    Death
    Date Received
    November 11, 2007
    Date of Event
    May 18, 2007
    Report Date
    February 19, 2008
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INOGEN IS IN THE PROCESS OF GATHERING MORE INFORMATION. AT THIS TIME, THERE IS NO EVIDENCE REGARDING MALFUNCTION OF THE DEVICE. INOGEN WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    FINAL REPORT 02/19/2008: (B)(6) DOWNLOADED DATA FROM THE DEVICE MEMORY AND PROVIDED THE DATA TO INOGEN FOR REVIEW AND ANALYSIS. AN EVAL BY INOGEN ENGINEERING REVEALED THE FOLLOWING: THE DEVICE HAD BEEN OPERATED FOR A TOTAL OF 20.5 DAYS (493 HOURS). THE OXYGEN CONCENTRATION DURING OPERATION WAS ALWAYS WITHIN SPEC. THE OPERATIONAL DATA FOR THE PERIOD THAT (B)(6) WAS ACTUALLY USING THE DEVICE CANNOT BE DISTINGUISHED FROM OPERATIONAL DATA FOR OTHER PERIODS SINCE THE DEVICE HAS NO REAL-TIME CLOCK. NEVERTHELESS, IN LIGHT OF THE FACT THAT THE OXYGEN CONCENTRATION WAS WITHIN SPEC DURING ALL 493 HOURS OF DEVICE OPERATION, INOGEN HAS CONCLUDED THAT THE DEVICE DID NOT MALFUNCTION AND DID NOT CONTRIBUTE TO (B)(6) DEATH.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT 01/04/2008: CLAIMS ADJUSTER FOR (B)(6) REPORTS THAT: (B)(6) WAS THE FIRST USER ON THE INOGEN ONE OXYGEN CONCENTRATOR ((B)(6)). AFTER (B)(6) DEATH, (B)(6) PICKED UP THE DEVICE FROM HIS HOME ON (B)(6) 2007. THE DEVICE WAS TESTED, NO PROBLEMS WERE FOUND AND IT WAS PLACED BACK INTO SERVICE. THE DEVICE WAS USED ON OTHER PTS AND WAS REGULARLY MAINTAINED. THERE WERE NO COMPLAINTS OR REPORTS OF PROBLEMS WITH THE DEVICE. IN (B)(6) 2007, WHEN (B)(6) BECAME AWARE OF THE ALLEGATIONS SURROUNDING (B)(6) DEATH, THEY RETRIEVED AND SECURED THE DEVICE, WHERE IT REMAINS. INOGEN REVIEWED DEVICE HISTORY RECORDS FOR THIS UNIT: THERE WERE NO PROBLEMS ENCOUNTERED DURING PRODUCTION OF THE DEVICE. THERE ARE NO RECORDS OF AFTER-MARKET SERVICE / REPAIR ON THE DEVICE. THERE ARE NO OTHER RECORDS OF CUSTOMER COMPLAINTS ON THE DEVICE. (B)(6) HAS NOT RETURNED THE DEVICE TO INOGEN. INOGEN HAS REQUESTED THAT MERCY DOWNLOAD DATA FROM THE DEVICE'S MEMORY AND PROVIDE TO INOGEN FOR ANALYSIS. INOGEN WILL SUBMIT A FOLLOW-UP REPORT WHEN IT RECEIVES THE DATA AND COMPLETES THE INVESTIGATION.

    Description of Event or Problem · 1

    ATTORNEY REPRESENTING FAMILY AND ESTATE OF AJN REPORTS HIS DEATH IN CORRESPONDENCE RECEIVED BY INOGEN IN 2007. THE LETTER ALLEGES THAT AJN WAS USING AN INOGEN ONE OXYGEN CONCENTRATOR WHILE TRAVELING. ATTORNEY SPECULATES THAT AJN WAS NOT AN APPROPRIATE CANDIDATE FOR INOGEN ONE. AS HE NEEDED A CONTINUOUS FLOW OF OXYGEN DURING SLEEP. THE INOGEN ONE PROVIDES A PULSE DOSE OF FLOW OF OXYGEN.

    Description of Event or Problem · 1

    FINAL REPORT 02/19/2008: NO ADD'L INFO.

    Description of Event or Problem · 1

    FOLLOW-UP REPORT 01/04/2008: CLAIMS ADJUSTER FOR (B)(6), A HOME CARE PROVIDER IN (B)(6), REPORTS THAT: THE EQUIPMENT WAS DELIVERED AND DEMONSTRATED TO (B)(6) ON (B)(6) 2007. ON A TRIP TO ( B)(6), (B)(6) AND WIFE STOPPED IN (B)(6) ON (B)(6) 2007. (B)(6) AND WIFE WENT TO BED AT APPROX 10PM. WIFE WOKE AT APPROX MIDNIGHT AND FELT (B)(6) HAND WAS COLD. (B)(6) WAS TAKEN TO THE EMERGENCY ROOM AT (B)(6), WHERE HE WAS PRONOUNCED DEAD ON ARRIVAL AT 00:49 AM ON (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOGEN ONE OXYGEN CONCENTRATOR CAW (PORTABLE OXYGEN GENERATOR) CAW INOGEN, INC. IO-100

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death