BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN G3 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 19730887 · Received July 12, 2024

    Report

    Report Number
    3004672275-2024-00031
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    March 15, 2024
    Report Date
    May 8, 2024
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    UDI-DI
    00817131020063
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN OF THE DEVICE HAS BEEN INITIATED. ONCE THE DEVICE IS RECEIVED AN INVESTIGATION WILL BE CONDUCTED AND A FOLLOWUP WILL BE SUBMITTED IF REQUIRED.

    Description of Event or Problem · 0

    ACCORDING TO THE PATIENT, THE POC BEGAN POWERING OFF ITS SELF WHICH LEAD TO THE PATIENTS DECLINE IN HEALTH DUE TO BEING UNABLE TO BREATH WHEN THE UNIT IS NOT WORKING AND THE PATIENT IS OUT IN PUBLIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271381 INOGEN G3 PORTABLE OXYGEN CONCENTRATOR INOGEN G3 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-300 00817131020063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H