BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3931116 · Received July 14, 2014

    Report

    Report Number
    1031452-2014-03450
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    May 28, 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

    Additional Manufacturer Narrative · 1

    PER REPAIR STATEMENT, THE ALARM WILL NOT FUNCTION, THE POWER SWITCH ON THE CONTROL PANEL HAS A SHORT CIRCUIT, THE EXCHANGE ASSEMBLY FOR THE MANIFOLD IS LEAKING, THE 3/8" HOSE CLAMP FOR THE MANIFOLD IS DEFECTIVE, AND THE ELBOW MALE FLARE FOR THE COMPRESSOR IS LEAKING.

    Description of Event or Problem · 1

    PER PROVIDER, POWER SWITCH HAS A SHORT CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411057 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other