BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4231348 · Received November 6, 2014

    Report

    Report Number
    1031452-2014-17812
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 15, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    INDEPENDENT REPAIR CENTER: CUSTOMER ALLEGED ALARMING/RED LIGHT AND THE KEY FAILURE IS THE VALVE IS STUCK. ASSOCIATED MALFUNCTIONS FOR THIS DEVICE; POPPET VALVE NOT SHIFTING, HEAT EXCHANGER COUPLING, SIEVE TUBES, COMPRESSOR INLET TUBE, CLAMPS, AND ZIP TIES ARE LEAKING, COOLING FAN AND MOUNTS ARE LOUD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714992 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other