BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 874698 · Received July 3, 2007

    Report

    Report Number
    1720753-2007-02979
    Event Type
    Malfunction
    Date Received
    July 3, 2007
    Date of Event
    June 12, 2007
    Report Date
    July 3, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GEHC SERVICE PERSONNEL FOUND TUBE IS ARCING AND NO EVIDENCE OR RESIDUE OF ARCING CAUSED BY CANDLESTICKS. MOVING THE HIGH VOLTAGE CABLE CAUSED THE VIDEO TO BECOME UNSTABLE AND A LOSS OF VIDEO TO THE WORKSTATION MONITOR, CAUSING SYSTEM TO DRIVE TO MAXIMUM TECHNIQUE. ORDER AND REPLACE X-RAY TUBE, HIGH VOLTAGE CABLE, AND THE INTERCONNECT CABLE HAD EXCESSIVE WEAR FROM NORMAL USE. REPLACED X-RAY TUBE, REMOVED PRIMARY AND SECONDARY COLLIMATOR FROM OLD TUBE AND PLACED THEM ON THE NEW TUBE. REPLACED HIGH VOLTAGE CABLE, INTERCONNECT CABLE, AND LEMO RECEPTACLE IAW THE SERVICE MANUAL. PERFORMED GENERATOR ALIGNMENTS AND FILAMENT CALIBRATION. PERFORMED BEAM ALIGNMENTS AND CAMERA ALIGNMENTS IAW SERVICE MANUAL. SYSTEM RESTORE TO FULL OPERATION, NO ARCING APPARENT IN TUBE AND VIDEO IS STABLE ON MONITORS. MEASURED MAXIMUM R/MIN TO ENSURE WITHIN SPECIFICATIONS OF LESS THAN 9.2 DURING NORMAL FLUORO AND LESS THAN 18 DURING HIGH LEVEL FLUORO. CUSTOMER REQUEST HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, SYSTEM LEFT MONITOR IS BLANK AND SYSTEM GOES TO MAXIMUM TECHNIQUE AND POPPING NOISE IS HEARD FROM THE X-RAY RUBE IN 2007 AND PHONE FOR SERVICE THE FOLLOW MORNING ON THE FOLLOWING DAY. THE PROBLEM OCCURRED WITH PATIENT ON THE TABLE AND UNDER ANESTHESIA. THE SYSTEM DID NOT WORK AFTER REBOOT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR