BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4101912 · Received September 19, 2014

    Report

    Report Number
    1031452-2014-10047
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 29, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    INDEPENDENT REPAIR CENTER: UNIT IS ALARMING OR HAS A RED LIGHT. THE POWER BOX HAS A SHORT CIRCUIT, THE FILTER IS MISSING FROM THE SOUND BOX, THE FILTER IS MISSING FROM THE CABINET, THE PE VALVE IS NOT SWITCHING, THE TIE WRAP IS DEFECTIVE, THE PILOT VALVE IS LEAKING, THE O-RING IS DEFECTIVE, AND THE TIE STRAP IS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581824 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other