BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 4002688 · Received July 9, 2014

    Report

    Report Number
    1720753-2014-05794
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 9, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SRAM WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED, FOUND TO BE WORKING AS INTENDED, AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE FE REPORTED THAT THE SYSTEM DOES NOT BOOT. THIS RESULTED IN A TOTAL LOSS OF IMAGING FUNCTIONALITY. THIS COULD CAUSE 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
    399215 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1