BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4092368 · Received September 16, 2014

    Report

    Report Number
    1031452-2014-09436
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 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

    DEALER ALLEGED THAT THE 4 WAY VALVE WAS LEAKING. PER INDEPENDENT REPAIR STATEMENT THE UNIT WAS ALARMING OR RED LIGHT. KEY FAILURE WAS THE 4 WAY VALVE WAS LEAKING. ADDITIONAL MALFUNCTIONS WERE THE HOSE CLAMPS AND TIE WRAPS WERE DEFECTIVE, PILOT VALVE WAS NOT SHIFTING, HEAT EXCHANGER WAS LEAKING AND THE MUFFLER HOUSING WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572823 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other