BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4120562 · Received September 26, 2014

    Report

    Report Number
    1031452-2014-11063
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 5, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER INDEPENDENT REPAIR CENTER STATEMENT, UNIT WAS LOW O2 OR YELLOW LIGHT. THE KEY FAILURE WAS THAT THE PILOT VALVE IN THE MANIFOLD WAS LEAKING. ADDITIONAL MALFUNCTIONS ARE THE O-RING FOR THE MANIFOLD AND THE TIE STRAPS FOR THE SIEVE BEDS WERE DEFECTIVE AND THE SOUND BOX FILTER AND CABINET FILTER WERE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601113 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other