BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 25334162 · Received May 29, 2026

    Report

    Report Number
    3004672275-2026-00148
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 29, 2026
    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
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS ESTIMATED. AS THE DEVICE IS NOT RETURNED, NO OTHER INFORMATION IS AVAILABLE AT THIS TIME TO DETERMINE ANY OTHER PROBABLE CAUSE AND/OR THE EXACT CAUSE OF THE EVENT. IF THE DEVICE IS RECEIVED AN INVESTIGATION WILL BE CONDUCTED AND A FOLLOW UP WILL BE SUBMITTED IF REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS DISPLAYING THE LOW OXYGEN MESSAGE AND STOPPED PRODUCING OXYGEN WHILE THEY WERE OUT, CAUSING BREATHING PROBLEMS AND LOWERED OXYGEN LEVELS. AS A RESULT, THE PATIENT WENT BACK TO THEIR CAR WHERE THEIR BACKUP OXYGEN TANK WAS AND TAKEN TO THE HOSPITAL. THE PATIENT WAS HOSPITALIZED FOR 3 DAYS. PATIENT HAS SINCE BEEN RELEASED AND RECEIVED THEIR REPLACEMENT DEVICE WHICH THEY STATE IS WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468657 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| L