BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 19730511 · Received July 12, 2024

    Report

    Report Number
    3004672275-2024-00032
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    March 25, 2024
    Report Date
    May 8, 2024
    Manufacturer
    INOGEN INC.
    Product Code
    CAW
    UDI-DI
    00817131020162
    PMA / PMN Number
    K032818
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT HAS RECEIVED A REPLACEMENT UNIT OVERNIGHT. 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, THE POC UNIT DIED WHILE HE WAS IN THE GROCERY STORE RESULTING IN A 911 CALL. THE UNIT HAD 42% BATTERY BUT WAS NO LONGER PRODUCING OXYGEN AND DISPLAYED A O2 LOW ERROR CODE. THE PATIENT IS PRESCRIBE O2 SETTINGS 2 TO 3. THE PATIENT WAS IN THE ICU IN FOR 3 DAYS. THE PATIENT RECEIVED OXYGEN, BREATHING TREATMENT AND STEROIDS. THE PATIENT IS NOW ON A LIFE VEST. THE EVENT IS STILL ONGOING. THE PATIENT ALSO NOTED THAT THERE WAS NO DUST ON COLUMNS, THE PARTICLE FILTERS WERE CLEAN, AND THERE WERE NO KINKS IN LINE. THE UNIT ALSO PRODUCED A LOUD BUZZING NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385613 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