BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 8791496 · Received July 15, 2019

    Report

    Report Number
    3009843463-2019-12345
    Event Type
    Death
    Date Received
    July 15, 2019
    Date of Event
    April 14, 2019
    Report Date
    July 13, 2019
    Manufacturer
    INOGEN INC.
    Product Code
    CAW
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    INOGEN BECAME AWARE ON JUNE 14, 2019 THAT THE PATIENT'S SON ALLEGED THE PATIENT PASSED AWAY DUE TO THE INOGEN AT HOME DEVICE "SUFFOCATING" THE PATIENT. THE PATIENT'S SON HAS REFUSED TO PROVIDE INOGEN WITH ANY FURTHER INFORMATION AND REFUSED TO RETURN THE DEVICE TO INOGEN FOR FURTHER INVESTIGATION. AT THE TIME OF THIS REPORT, INOGEN WAS UNABLE TO GATHER FURTHER INFORMATION, THAT REASONABLY SUGGESTS, THAT A DEVICE MALFUNCTION OCCURRED OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585047 INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN INC. IO-300

    Patients

    Seq Age Sex Outcome Treatment
    1 Death