BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3902191 · Received February 24, 2014

    Report

    Report Number
    1720753-2014-01755
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 24, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE X-RAY TUBE AND THE HIGH VOLTAGE TANK WERE REPLACED 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 REPORTED AN OVERLOAD FAULT ERROR MESSAGE. THIS ERROR CAUSES THE SYSTEM TO SHUT DOWN, RESULTING IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113506 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1