BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4200582 · Received October 24, 2014

    Report

    Report Number
    1031452-2014-16131
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    October 6, 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

    INDEPENDENT REPAIR CENTER CUSTOMER ALLEGED UNIT HAS LOW O2 OR YELLOW LIGHT AND THE KEY FAILURE IS THE PILOT VALVE FOR THE MANIFOLD IS LEAKING. ADDITIONAL MALFUNCTIONS INCLUDE THE POWER SWITCH FOR THE CONTROL PANEL HAD A SHORT CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678870 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PW

    Patients

    Seq Age Sex Outcome Treatment
    1 Other