BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 24384130 · Received February 18, 2026

    Report

    Report Number
    3004672275-2026-00030
    Event Type
    Death
    Date Received
    February 18, 2026
    Date of Event
    January 27, 2026
    Report Date
    March 25, 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
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS RETURNED WITH A DEATH NC; HOWEVER THE ISSUE WAS TRACED TO HIGH PRESSURE CAUSED BY THE MUFFLER BEING FILLED WITH DUST, WHICH RESULTED IN A BLOCKAGE IN THE FEED PORT AND LOW SIEVE LIFE (0), LOW INTERNAL (80.8%) & LOW EXTERNAL 02(88.8%). FURTHERMORE, THE PSA CYCLE (ACCORDING TO THE DATA LOG) BEING HIGH (14) IS AN INDICATION THE ZEOLITE IS GETTING CONTAMINATED BY MOISTURE. ADDITIONALLY, THE FAN WAS MISALIGNED AND CONTACTING THE ACCUMULATOR LIKELY DUE TO HIGH-IMPACT INCIDENT, POSSIBLY FROM THE UNIT BEING DROPPED. UIP, TOP HOUSING & LOWER HOUSING WERE ALSO REPLACED DUE TO COSMETIC DAMAGE.

    Additional Manufacturer Narrative · 0

    AS DEVICE WAS NOT RETURNED, NO OTHER INFORMATION IS AVAILABLE AT THIS TIME TO DETERMINE ANY OTHER PROBABLE CAUSE AND/OR THE EXACT CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT LOST POWER IN THEIR HOME AND HAD TO LEAVE IT DURING A WINTER STORM. THE PATIENT WAS USING THEIR PORTABLE OXYGEN CONCENTRATOR DEVICE AS THEY WERE UNABLE TO TAKE THEIR STATIONARY UNIT WITH THEM. THE DEVICE WAS NOT PRODUCING ENOUGH OXYGEN. AS A RESULT, THEIR OXYGEN LEVELS DROPPED AND THEY STARTED TO FEEL HOT AND SICK, SO 911 WAS CALLED. PATIENT PASSED AWAY WHILE WAITING FOR EMERGENCY MEDICAL SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311612 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