BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 24559910 · Received March 10, 2026

    Report

    Report Number
    3004672275-2026-00040
    Event Type
    Death
    Date Received
    March 10, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 10, 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
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS NOT RETURNED FOR EVALUATION. 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'S UNIT DID NOT PROVIDE ENOUGH OXYGEN. AS A RESULT, THE PATIENT WAS HOSPITALIZED AND PASSED AWAY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329792 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 Death