BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1182734 · Received October 3, 2008

    Report

    Report Number
    1720753-2008-25021
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 25, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE LEMO CONNECTOR WAS REPAIRED AND THE X-RAY TUBE TEMPERATURE SENSOR WAS REPLACED DURING THE SVC CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM HAD AN X-RAY OVER TEMPERATURE ERROR AND THE TECHNIQUE TRACKS TO MAXIMUM. ALSO, THERE ARE BLACK BARS ON THE LEFT MONITOR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1