BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4110237 · Received September 23, 2014

    Report

    Report Number
    1031452-2014-10538
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER INDEPENDENT REPAIR CENTER STATEMENT, THE UNIT WAS ALARMING / RED LIGHT. THE KEY FAILURE WAS THE 4-WAY VALVE WAS STUCK. ADDITIONAL MALFUNCTIONS WERE THE COMPRESSOR WAS LOUD, THE HEAT EXCHANGER WAS LEAKING, THE POPPET VALVE WAS NOT SHIFTING, THE TY WRAPS WERE LEAKING, THE GEAR CLAMPS WERE LEAKING AND THE ELBOW FOR THE HEAT EXCHANGER WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590003 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PW

    Patients

    Seq Age Sex Outcome Treatment
    1 Other