BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4211171 · Received October 29, 2014

    Report

    Report Number
    1031452-2014-16552
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    August 4, 2014
    Report Date
    October 8, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATES THAT IT KEEPS GIVING AN ERROR CODE 1 RED AND 1 GREEN FOR MAJOR LEAK AND SHUTS DOWN. DEALER UNABLE TO FIND ANYTHING LEAKING AND HAS SPOKEN WITH OUR TECHNICIANS AND NO RESOLUTION. A PC BOARD WAS REPLACED AND THAT DIDN'T FIX IT EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692307 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other