BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 19671320 · Received July 3, 2024

    Report

    Report Number
    3004672275-2024-00041
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 3, 2024
    Report Date
    July 3, 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

    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, HE WAS RUNNING ERRANDS WITH HER. SHE EXPLAINED THAT HE HAS STARTED TO EXACERBATE BECAUSE THE PORTABLE WAS NOT DELIVERING ANY OXYGEN. EXACERBATE IS THE WORD SHE USES. SHE SAID THAT SHE TOOK HIM TO THE HOSPITAL SINCE THEY WERE RUNNING ERRANDS. SHE DID NOT SAY THAT SHE CALLED 911OR CALL ANYBODY. HE HAS CONGESTED HEART FAILURE AND EMPHYSEMA. SHE TOOK HIM TO THE HOSPITAL WHERE HE STAYED FOR 1 WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901633 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