BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 24887071 · Received April 15, 2026

    Report

    Report Number
    3004672275-2026-00094
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    March 21, 2026
    Report Date
    April 15, 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
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT IS ESTIMATED. THE UNIT WAS RETURNED FOR EVALUATION ON 30-MAR-2026. THE UNIT WAS RETURNED WITH A OXYGEN ERROR COMPLAINT, WHICH WAS CONFIRMED DURING TESTING. THE ISSUE WAS TRACED TO A STUCK FEED WASTE VALVE CAUSED BY DEBRIS INSIDE IT. ALSO, THE MUFFLER BEING FILLED WITH DUST, WHICH RESULTED IN A BLOCKAGE IN THE FEED PORT, AND DAMAGED COMPRESSOR MOUNT DUE TO COMPRESSOR VIBRATION. ADDITIONALLY, DATA LOG SHOWS THE '02 DELIVERY ERROR', POSSIBLY THIS CAN HAPPEN WHEN CANNULA IS NOT POSITIONED CORRECTLY IN THEIR NOSE. THE UIP & HOUSING WERE ALSO REPLACED DUE TO COSMETIC DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S UNIT HAD AN OXYGEN DELIVERY ERROR. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE AND THE ERROR CODE PERSISTED. AS A RESULT, THE PATIENT WAS RUSHED TO THE EMERGENCY ROOM. A REPLACEMENT UNIT WAS SENT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT THE PATIENT DID NOT WANT TO ANSWER ANY FURTHER QUESTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946925 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 Other