BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4043594 · Received August 28, 2014

    Report

    Report Number
    1031452-2014-07580
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Report Date
    August 4, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER INDEPENDENT REPAIR CENTER STATEMENT, THE UNIT IS ALARMING OR RED LIGHT. THE KEY FAILURE IS THE SIEVE BEDS ARE SATURATED. ADDITIONAL MALFUNCTIONS ARE THE PILOT VALVE IS NOT SHIFTING, THE ON/OFF SWITCH HAS NO ALARM, AND THE TIE WRAP IS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525851 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other