BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4091102 · Received September 16, 2014

    Report

    Report Number
    1031452-2014-09380
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 25, 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, THE UNIT HAS LOW O2 OR YELLOW LIGHT. THE KEY FAILURE IS THE PILOT VALVE FOR THE MANIFOLD IS CONTAMINATED. ADDITIONAL MALFUNCTIONS ARE THE ON/OFF SWITCH FOR THE CONTROL PANEL HAS A SHORT CIRCUIT, THE INTAKE FILTER FOR THE SOUND BOX IS DIRTY/STAINED, AND THE PILOT VALVE O-RING AND TIE STRAPS FOR THE SIEVE BEDS ARE DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572673 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other