BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3961991 · Received July 28, 2014

    Report

    Report Number
    1031452-2014-04540
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    June 18, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PER REPAIR STATEMENT, THE UNIT IS ALARMING OR RED LIGHT. THE KEY FAILURE IS THE CLAMPS ON THE MANIFOLD WERE CAUSING LEAKING FROM THE HOSE.

    Description of Event or Problem · 1

    PER REPAIR STATEMENT, THE UNIT IS ALARMING OR RED LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437478 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other