BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4102835 · Received September 19, 2014

    Report

    Report Number
    1031452-2014-10115
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 28, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER INDEPENDENT REPAIR CENTER STATEMENT, THE UNIT IS ALARMING OR RED LIGHT. THE KEY FAILURE IS THE HOSE CLAMPS FOR THE MANIFOLD WERE REPLACED. ADDITIONAL MALFUNCTION IS THE ZIP TIE FOR THE HEAT EXCHANGER WERE REPLACED. THE HEAT EXCHANGER WAS REATTACHED TO THE MANIFOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584762 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other