BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN AT HOME OXYGEN CONCENTRATOR

    MDR report key: 23729298 · Received December 5, 2025

    Report

    Report Number
    3004672275-2025-00176
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    November 9, 2025
    Report Date
    December 5, 2025
    Manufacturer
    INOGEN INC.
    Product Code
    CAW
    UDI-DI
    00817131020148
    PMA / PMN Number
    K132489
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS RETURNED FOR EVALUATION ON 25-NOV-2025. THE RETURN REASON OF OXYGEN ERROR IS CONFIRMED SINCE ZEOLITE DUST EXISTED IN THE UNIT, WHICH WAS POSSIBLY CAUSED BY THE BREAKDOWN OF THE ZEOLITE PARTICLES. THIS OCCURS WHEN THE ZEOLITE RUBS AGAINST ONE ANOTHER. OVER TIME THIS CAN LEAD TO MULTIPLE ERRORS. THIS DUST IS SO FINE IT CAN ESCAPE THE COLUMN FRITS AND CONTAMINATE THE MUFFLER WITH ZEOLITE DUST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S STATIONARY UNIT STOPPED WORKING. IT WAS BEEPING AND THERE WAS A FINE WHITE DUST COMING FROM THE UNIT. AS A RESULT, THE PATIENT'S OXYGEN SATURATION LEVELS HAD DROPPED SIGNIFICANTLY CAUSING THEIR FINGERS TO TURN BLUE AND CAUSING THEM TO FEEL DISORIENTED. THEY WERE UNABLE TO ACCESS THEIR BACKUP PORTABLE UNIT, HOWEVER THE PATIENT'S SON PROVIDED A BACKUP OXYGEN SOURCE TO ENSURE THE PATIENT GOT ENOUGH OXYGEN. THE PATIENT DID NOT HAVE TO GO THE HOSPITAL NOR DID THEY HAVE TO CONTACT EMERGENCY SERVICES. THE PATIENT HAS RECEIVED A REPLACEMENT UNIT AND IT IS WORKING WELL FOR THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2876622 INOGEN AT HOME OXYGEN CONCENTRATOR INOGEN AT HOME OXYGEN CONCENTRATOR CAW INOGEN INC. GS-100 00817131020148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| L