BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3832919 · Received March 17, 2014

    Report

    Report Number
    9680959-2014-00363
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 17, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE FE REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. 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
    156963 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1