BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 19842954 · Received July 26, 2024

    Report

    Report Number
    3004672275-2024-00053
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 26, 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
    NM, 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 FOLLOW UP WILL BE SUBMITTED IF REQUIRED.

    Description of Event or Problem · 0

    ACCORDING TO THE PATIENT, THEY WERE ON THEIR WAY TO A CARDIOLOGY APPOINTMENT WHEN THEY SAW A YELLOW, THEN RED FLASHING LIGHT AND O2 DELIVERY ERROR. THEN THERE WAS NO O2. THE PATIENT WAS SHORT OF BREATH, GASPING FOR AIR. THE PATIENT WAS IN THE DOCTORS OFFICE WHEN THE EVENT OCCURRED AND THEREFORE DID NOT HAVE AN ALTERNATIVE OXYGEN SUPPLY. THE DOCTOR LISTENED TO THE PATIENTS LUNGS AND SENT THEM TO THE ER WHERE THEY SPENT THE DAY UNTIL THEY GOT A BOTTLE OF O2 TO GO HOME WITH AND BREATHING TREATMENT. THE PATIENT STATED THAT THEY RECEIVED A REPLACEMENT UNIT BUT ANOTHER O2 DELIVERY ERROR SHOWED UP AND THEY DID NOT FEEL O2 COMING FROM THE POC. AN ADDITIONAL REPLACEMENT HAS BEEN SENT AND THE PATIENT IS USING THEIR HOME UNIT IN THE MEANTIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586387 INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-300 00817131020063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization