BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 19771853 · Received July 18, 2024

    Report

    Report Number
    3004672275-2024-00048
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    April 17, 2024
    Report Date
    July 18, 2024
    Manufacturer
    INOGEN INC
    Product Code
    CAW
    UDI-DI
    00817131020162
    PMA / PMN Number
    K032818
    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 PORTABLE OXYGEN CONCENTRATOR STARTED TO BEEP, NO AIR WAS COMING OUT OF THE PORTABLE, AND THAT SHE BEGAN LOSING OXYGEN. SHE COULD NOT BREATH AND SHE WAS LOSING OXYGEN BECAUSE THE PORTABLE WAS NOT WORKING. SHE IS ON OXYGEN 24/7. THE PATIENT STATED THAT THE POC KEPT SHUTTING DOWN BECAUSE THE POWER PORT WAS DAMAGE. SHE EXPLAINED THAT THE ACPS WOULD WIGGLE IN THE BACK OF THE MACHINE, AND THEY WOULD HAVE TO MOVE IT AROUND TO GET A CHARGE. SHE DOESN'T HAVE ANY OTHER UNIT TO USE FOR BACK UP. SHE WAS LOSING OXYGEN, SO HER HUSBAND TOOK HER TO THE HOSPITAL WHERE SHE WAS ADMITTED FOR ONE DAY. THEY GAVE HER BREATHING TREATMENT, ALBUTEROL, AND OXYGEN. THE HOSPITAL RENTED HER A TANK TO GO HOME UNTIL SHE RECEIVED HER UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919144 INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN INC IO-500 00817131020162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization