BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ONE G3 HIGH FLOW PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 25260142 · Received May 22, 2026

    Report

    Report Number
    3004672275-2026-00144
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 22, 2026
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    UDI-DI
    00817131020063
    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

    B3: DATE OF EVENT IS ESTIMATED. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE. THE RETURN REASON OF SERVICE NEEDED IS CONFIRMED SINCE MOTHERBOARD FAILED FOR NO POWER SINCE Q10 SHORTED, VOLTAGE IS BEING PULLED TO 12V.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS NOT CHARGING AND THE PATIENT WAS HOSPITALIZED. IT WAS NOTED THAT THE PATIENT HAS A STATIONARY OXYGEN CONCENTRATOR THAT THEY CAN USE. IT IS UNCONFIRMED IF THE REASON FOR HOSPITALIZATION WAS DUE TO THE DEVICE ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AS MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574414 INOGEN ONE G3 HIGH FLOW PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G3 HIGH FLOW PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-300 00817131020063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization