BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2971763 · Received February 6, 2013

    Report

    Report Number
    1720753-2013-01516
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 6, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE EVALUATED THE SYS AND FOUND THE REPORTED ERROR IN THE SYS LOGS, BUT COULD NOT REPRODUCE THE REPORTED PROBLEM. THE CUSTOMER DECIDED TO CONTINUE USING THE SYS AND WILL NOTIFY GE IF THE PROBLEM RECURS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A ZAPPING SOUND (ARCING) AND BURNING SMELL. THE FSE REPORTED COMMUNICATION FAILURE ERRORS IN THE LOG FILES. THIS ERROR MAY RESULT IN A SYSTEM LOCK UP, NO BOOT, OR SHUT DOWN SITUATION DEPENDING ON WHEN THE LOSS OF COMMUNICATION OCCURS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51210 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1