BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 25191690 · Received May 15, 2026

    Report

    Report Number
    3004672275-2026-00135
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 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
    TX, 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 HAD BURST OR BROKEN COLUMNS. AS A RESULT, THE UNIT WAS NOT PRODUCING ENOUGH OXYGEN LEADING TO A LOSS IN THEIR VISION. HOWEVER, THERE WAS NO FURTHER INTERVENTION REPORTED AT THAT TIME. 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
    274685 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