BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 25256243 · Received May 22, 2026

    Report

    Report Number
    3004672275-2026-00142
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 25, 2026
    Report Date
    May 22, 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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS ESTIMATED. THE UNIT WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S UNIT STOPPED WORKING WHILE THEY WERE DRIVING. AS A RESULT, THE PATIENT WAS HOSPITALIZED DUE TO THE DEVICE NOT WORKING. A REPLACEMENT UNIT WAS SENT TO THE PATIENT. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576702 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