BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 21229794 · Received January 24, 2025

    Report

    Report Number
    3004672275-2025-00009
    Event Type
    Death
    Date Received
    January 24, 2025
    Date of Event
    December 16, 2024
    Report Date
    January 22, 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
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN OF THE DEVICE HAS BEEN INITIATED. ONCE THE DEVICE IS RECEIVED AN INVESTIGATION WILL BE CONDUCTED AND A FOLLOW UP WILL BE SUBMITTED IF REQUIRED.

    Description of Event or Problem · 0

    ACCORDING TO THE PATIENT'S WIFE, HER HUSBAND DID HAVE TO GO TO HOSPITAL AND DID EXPERIENCE ANY ADVERSE HEALTH CONSEQUENCES FROM EVENT. HE WAS TAKEN TO THE HOSPITAL VIA AMBULANCE. IT WAS REPORTED THAT UPON ARRIVAL THE PATIENT WAS NON-RESPONSIVE. SHE REPORTED A BATTERY CONNECTION ISSUE, AND HER HUSBAND HAD LACK OF O2. THERE WERE NO REPORTED AUDIBLE OR VISUAL ALARMS AT THE TIME OF THE EVENT. THERE WAS ALTERNATIVE OXYGEN SUPPLY FOR USE DURING THE DEVICE ISSUE. THE PATIENT EXPERIENCED A MASSIVE HEART ATTACK AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556137 INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-300 00817131020063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| D