BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3964449 · Received July 29, 2014

    Report

    Report Number
    1031452-2014-04650
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    June 23, 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 WAS ALARMING OR RED LIGHT. THE KEY FAILURE WAS DUE TO GEAR CLAMPS ON THE MANIFOLD CAUSING THE HOSE TO BE LOOSE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441121 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other