BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3162109 · Received June 3, 2013

    Report

    Report Number
    1720753-2013-06689
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 17, 2013
    Report Date
    June 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED A POWER SUPPLY. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE FSE REPORTED 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 OCCURS. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THIS COULD RESULT IN THE DELAY OR CANCELLATION OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242941 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 8800

    Patients

    Seq Age Sex Outcome Treatment
    1