BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 6800

    MDR report key: 1133699 · Received August 20, 2008

    Report

    Report Number
    1720753-2008-24837
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 22, 2008
    Report Date
    August 20, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SETTINGS WERE CHANGED 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 THAT THE 6800 SYSTEM WOULD NOT RESPOND AFTER GOING INTO SLEEP MODE PRIOR TO A CASE. THE 6800 SYSTEM HAD TO BE REBOOTED, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1