BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4151234 · Received October 8, 2014

    Report

    Report Number
    1031452-2014-12618
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 16, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER INDEPENDENT REPAIR CENTER STATEMENT THE UNIT HAD LOW O2 OR YELLOW LIGHT. THE KEY FAILURE WAS THE SIEVE BEDS WERE SATURATED. ADDITIONAL MALFUNCTIONS INCLUDE THE 4 WAY VALVE WAS CONTAMINATED, THE VALVE OPERATOR WAS LEAKING, THE CLAMPS WERE LEAKING, THE PM KIT WAS DIRTY, AND THE ZIP TIES WERE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633015 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other