BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGOFIT

    MDR report key: 10940209 · Received December 2, 2020

    Report

    Report Number
    MW5098188
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 23, 2020
    Report Date
    December 2, 2020
    Manufacturer
    UNK
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHEN DEVICE STOPPED WORKING I BECOME VERY DYSPNEIC AND LIGHTHEADED WITH AN SAO2 OF 83%. IN SEVERAL OCCASIONS THE OXYGEN CONCENTRATOR STOPPED WORKING AND WOULD NOT RESTART FOR OVER AN HOUR. ON THE MOST RECENT I WAS WALKING ABOUT A MILE FROM MY HOME AND THE DEVICE STOPPED AND WOULD RESTART FOR ABOUT 30 SECOND THEN EVENTUALLY WOULD NOT RESTART. APPLIED HOME HEALTHCARE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402233 OXYGOFIT GENERATOR, OXYGEN, PORTABLE CAW UNK 1400-2000

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other