BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1083754 · Received July 29, 2008

    Report

    Report Number
    1720753-2008-24037
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 28, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE X-RAY TUBE WAS REPLACED 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 9800 SYSTEM MADE A LOUD POPPING NOISE, THEN THE LEFT MONITOR WENT BLANK DURING A CASE. THE 9800 SYSTEM HAD TO BE REBOOTED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. 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