BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4205490 · Received October 28, 2014

    Report

    Report Number
    1031452-2014-16399
    Event Type
    Malfunction
    Date Received
    October 28, 2014
    Report Date
    October 7, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER CALLED IN TO TROUBLESHOOT WITH TECH HE WAS GETTING ONE RED TWO 2 GREEN LIGHTS, HIGH PRESSURE NOT SWITCHING. UNIT SHUTTING DOWN WITH 1R, 2GR CODE. DEALER HAS REPLACED BEDS, 4 WAY AND HAS OHM'S OUT PILOT VALE AT 180 OHMS. SOUNDS LIKE PILOT VALVE COULD BE HANGING UP. SENDING PCB ALSO IF PILOT VALVE DOESN'T FIX ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688284 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other