BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3101514 · Received May 2, 2013

    Report

    Report Number
    1720753-2013-05628
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 2, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE BIOS WERE RESET 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, "NO MORE IMAGES". THE FSE NOTED, "SYSTEM NOT BOOTING UP, BLACK SCREENS." THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193070 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 6800

    Patients

    Seq Age Sex Outcome Treatment
    1