BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN ONE OXYGEN CONCENTRATOR

    MDR report key: 1456268 · Received August 26, 2009

    Report

    Report Number
    3004672275-2009-00001
    Event Type
    Death
    Date Received
    August 26, 2009
    Date of Event
    May 7, 2009
    Report Date
    August 27, 2009
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER BEING RELEASED FROM A HOSPITAL, THE PATIENT BOARDED AN AIRCRAFT. APPROXIMATELY ONE HOUR INTO FLIGHT, THE PATIENT WAS NOT ABLE TO POWER THE DEVICE. THE AIRCRAFT THEN PROVIDED THE PATIENT OXYGEN FOR THE REMAINING 1 1/2 HOURS OF THE FLIGHT. UPON LANDING, THE PATIENT WAS MET BY PARAMEDICS, BUT WENT HOME WITHOUT FURTHER MEDICAL ASSISTANCE AND CONTINUED TO USE THE DEVICE, BUT HAD TO STOP TWICE BECAUSE THE PRODUCT ALARMED. THE NEXT DAY, THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT PASSED AWAY ONE WEEK LATER WHILE HOSPITALIZED FOR PNEUMONIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death