BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN G3 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 19730558 · Received July 12, 2024

    Report

    Report Number
    3004672275-2024-00036
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    May 26, 2024
    Report Date
    June 20, 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

    THE PATIENT HAS RECEIVED A REPLACEMENT DEVICE 2 DAYS AFTER THE EVENT. 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 PATIENTS WIFE, THE POC DISPLAYED AN O2 DELIVERY MESSAGE AND WAS NOT WORKING. SHE THEN PUT THE PATIENT ON THE HOME UNIT BUT HE WAS STILL NOT RECEIVING OXYGEN. THE PATIENTS WIFE EXPLAINED THAT SOMETIMES THAT THE HOME UNIT DOES WORK AND HAD TO BE REPAIRED. SHE COULD NOT REMEMBER IF THE HOME UNIT IS AN INOGEN PRODUCT. SO, BOTH THE POC AND THE HOME UNIT WAS NOT WORKING AT ALL AND HE IS ON OXYGEN 24/7. THE PATIENT WENT TO THE HOSPITAL DUE TO THE LACK OF A SOURCE OF OXYGEN. THE HOSPITAL GAVE HIM BREATHING TREATMENT, OXYGEN AND DID A CHEST XRAY. THE PATIENT COULD NOT RETURN UNTIL ANOTHER POC AND HOME UNIT ARRIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346054 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 Hospitalization| O