BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 20021414 · Received August 21, 2024

    Report

    Report Number
    3004672275-2024-00058
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 19, 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
    CA, 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 COULD NOT CHARGE THEIR POC AND IT SAID LOW OXYGEN. THE PATIENT HAD TROUBLE BREATHING AND FELT WEAK. THEIR O2 LEVEL DROPPED TO 63% AND THEY BECAME DISTRESSED. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND WAS ADMITTED WITH INFLAMED LUNGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397290 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