BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3961993 · Received July 28, 2014

    Report

    Report Number
    1031452-2014-04541
    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 WAS ALARMING OR RED LIGHT. THE KEY FAILURE WAS THE POPPET VALVE ON THE SOLENOID HAVING FOREIGN SUBSTANCE IN IT. ADDITIONALLY, THE CLAMP ON THE MANIFOLD WAS CAUSING LEAKING FROM THE HOSE, THE HEAT EXCHANGER WAS LEAKING, AND THE SMART PACK WAS DIRTY.

    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
    438203 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other