BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4060397 · Received September 4, 2014

    Report

    Report Number
    1031452-2014-08126
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Report Date
    August 7, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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 LEAKING. ADDITIONAL MALFUNCTIONS WERE TIE WRAP INSTALLED, CLAMP INSTALLED, 4 WAY VALVE LEAKING AND POPPET VALVE WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542689 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other