BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3970357 · Received July 31, 2014

    Report

    Report Number
    1031452-2014-04938
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    June 26, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER USER, THE UNIT WAS ALARMING. PROVIDER STATES SINCE THE UNIT HAS BEEN IN THE SHOP IT HAS NOT ALARMED BUT HE CAN HEAR THAT THE COMPRESSOR IS LOUDER THAN IT NORMALLY WOULD BE. PROVIDER STATES IT SOUNDS LIKE IT WORKING HARDER THAN NORMAL TO RUN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447952 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other