BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4212340 · Received October 30, 2014

    Report

    Report Number
    1031452-2014-16751
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 8, 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

    INDEPENDENT REPAIR CENTER CUSTOMER ALLEGED ALARM WILL NOT FUNCTION AND THE KEY FAILURE IS THE COMPRESSOR IS KNOCKING/NOISY. ADDITIONAL MALFUNCTIONS INCLUDE THE POWER SWITCH FOR THE CONTROL PANEL HAS A SHORT CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695584 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other