BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 20022628 · Received August 21, 2024

    Report

    Report Number
    3004672275-2024-00059
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 22, 2024
    Report Date
    August 20, 2024
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    UDI-DI
    00817131020162
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT HAS RECEIVED A REPLACEMENT UNIT. A RETURN OF THE DEVICE HAS BEEN INITIATED. ONCE THE DEVICE IS RECEIVED AN INVESTIGATION WILL BE CONDUCTED AND A FOLLOW UP WILL BE SUBMITTED IF REQUIRED.

    Description of Event or Problem · 0

    ACCORDING TO THE PATIENT, THEY EXPERIENCED SHORTNESS OF BREATH RELATED TO THE POC. THE UNIT STOPPED WORKING AND RECEIVED AN ERROR MESSAGE. THEIR HUSBAND TOOK THEM TO THE EMERGENCY ROOM WHERE THEY WERE KEPT OVERNIGHT UNTIL ARRANGEMENTS WERE MADE FOR THEM TO RETURN HOME WITH A STATIONARY CONCENTRATOR. DURING THE EVENT, THE PATIENT DID NOT HAVE AN ALTERNATIVE OXYGEN SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2359108 INOGEN G5 PORTABLE OXYGEN CONCENTRATOR INOGEN G5 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-500 00817131020162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization