BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4040485 · Received August 27, 2014

    Report

    Report Number
    1031452-2014-07116
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Report Date
    July 29, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 MANIFOLD VAVLE IS NOT SHIFTING FULLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521465 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other