BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4041002 · Received August 27, 2014

    Report

    Report Number
    1031452-2014-07422
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Report Date
    July 30, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER INDEPENDENT REPAIR CENTER STATEMENT, THE UNIT WAS ALARMING OR RED LIGHT. THE KEY FAILURE WAS THE SIEVE BEDS WERE SATURATED. ADDITIONAL MALFUNCTIONS WERE CLAMP HOSE LEAKING, TIE WRAPS LEAKING, MUFFLER WAS CLOGGED AND THE PILOT VALVE IS NOT SHIFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521992 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other