BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1021713 · Received March 19, 2008

    Report

    Report Number
    1720753-2008-19697
    Event Type
    Malfunction
    Date Received
    March 19, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 17, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. REPLACED THE X-RAY TUBE, TUBE HOUSING TEMPERATURE SENSOR AND CUSTOMER PROVIDED HIGH VOLTAGE CABLE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HIGH VOLTAGE CABLES ON THE 9800 SYSTEM ARE MAKING "POPPING" NOISES WHERE THEY CONNECT TO THE X-RAY TUBE. IT WAS NOTED THAT THIS IS A RECURRING ISSUE. THERE WAS NO REPORT OF PT INJURY.

    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