BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2802515 · Received October 19, 2012

    Report

    Report Number
    1720753-2012-08451
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 19, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE X-RAY TUBE, HIGH VOLTAGE TANK, FILAMENT DRIVE, GENERATOR DRIVE, GENERATOR INTERFACE BOARD, AND THE HIGH VOLTAGE REGULATOR BOARD WERE 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

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS ARCING AND SHUT DOWN WITHOUT COMMAND. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1