BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN AT HOME OXYGEN CONCENTRATOR

    MDR report key: 19955842 · Received August 9, 2024

    Report

    Report Number
    3004672275-2024-00019
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    February 27, 2024
    Report Date
    February 28, 2024
    Manufacturer
    INOGEN, INC
    Product Code
    CAW
    UDI-DI
    00817131020148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PATIENT STATED THAT HE WAS RUNNING THE STATIONARY MACHINE AT HOME WHEN HE STARTED SMELLING A BURNING SMELL "WHEN THE MACHINE MESSED UP". HE TURNED IT OFF AND HE STRUGGLED BREATHING SO HE STARTED USING HIS POC, BUT HE WAS STILL HAVING A HARD TIME BREATHING. CALLED 911 BUT HE DID NOT REMEMBER HOW MANY DAYS HE WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514949 INOGEN AT HOME OXYGEN CONCENTRATOR INOGEN AT HOME OXYGEN CONCENTRATOR CAW INOGEN, INC GS-100 00817131020148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other