BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN G3HF OXYGEN CONCENTRATOR

    MDR report key: 23075765 · Received September 17, 2025

    Report

    Report Number
    3004672275-2025-00134
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    August 26, 2025
    Report Date
    September 17, 2025
    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
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS RECEIVED FOR INVESTIGATION ON SEPTEMBER 03, 2025. THERE WAS CONFIRMATION FOR THE RETURN REASON OF BATTERY CONNECTION DEFECT. NO ACCESSORIES WERE RECEIVED WITH THE UNIT. THE UNIT WILL BE SCRAPED AFTER THE APPROVAL OF THIS FIR DOCUMENT AS THE UNIT HAS BEEN MORE THAN 5 YEARS SINCE IT'S PRODUCTION. THE PATIENT RECEIVED A REPLACEMENT UNIT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE PATIENT CALLED INOGEN TO REPORT THAT THE DEVICE WAS NOT PROVIDING ADEQUATE OXYGEN, WITH LEVELS DROPPING TO 86% WHILE WALKING AND 89% WHILE SITTING. HE MENTIONED THAT HE HAS BEEN MONITORING THE DEVICE CLOSELY SINCE HIS HOSPITAL STAY FROM ON (B)(6) AND WENT TO THE HOSPITAL THE DAY OF THE INCIDENT. THE PATIENT IS BACK HOME RECOVERING AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730395 INOGEN G3HF OXYGEN CONCENTRATOR INOGEN G3HF OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-300 00817131020063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization