BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3911884 · Received May 13, 2014

    Report

    Report Number
    1720753-2014-04135
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 13, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE TANK WAS REPLACED AND THE GENERATOR WAS CALIBRATED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF AN OVERLOAD FAILURE ERROR MESSAGE. THIS MESSAGE WILL RESULT IN A SHUT DOWN SITUATION ATTRIBUTED TO ARCING. THERE ARE NO REPORTS OF PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285319 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1