BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3063550 · Received April 12, 2013

    Report

    Report Number
    1720753-2013-04932
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 12, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS CLEANED AND REGREASED 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

    IT WAS REPORTED THE SYSTEM HAD AN OVERLOAD FAULT ERROR MESSAGE DURING TESTING. THIS ERROR CAUSES THE SYSTEM TO SHUT DOWN. THIS RESULTED IN A RECOVERABLE 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
    159210 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1