BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3941926 · Received July 17, 2014

    Report

    Report Number
    1031452-2014-03761
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 9, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER REPORTS THE UNIT GETS VERY HOT AND SHUTS DOWN AFTER 3-4 HOURS OF RUNNING. DEALER ALSO REPORTS WHEN HE EVALUATED IT HE NOTICED 2 RED LIGHTS AND 1 GREEN LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418237 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other