BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3984303 · Received August 6, 2014

    Report

    Report Number
    1031452-2014-05360
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 7, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THE UNIT IS RUNNING HOT AND UPON EVALUATION, HE NOTICED THE TUBING IS CLOUDY AND THERE IS SMOKE FILTRATION THROUGHOUT THE UNIT. DEALER STATED HE BELIEVES THE END-USER WHO WAS RENTING THE CONCENTRATOR IS A SMOKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461305 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other