BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2820464 · Received October 31, 2012

    Report

    Report Number
    1720753-2012-08958
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 31, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE KVP CONTROLLER BOARD AND THE INTERFACE BOARD. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A COMMUNICATION FAILURE ERROR MESSAGE. THIS ERROR MAY RESULT IN A SYSTEM LOCK UP, NO BOOT, OR SHUT DOWN SITUATION DEPENDING ON WHEN THE LOSS OF COMMUNICATION OCCURRED. THIS COULD RESULT IN ADDITIONAL UNNECESSARY DELAY AND/OR ANESTHESIA. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1