BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2192859 · Received July 25, 2011

    Report

    Report Number
    1720753-2011-20364
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 25, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    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 ONSITE INVESTIGATION. THE BATTERY VOLTAGE WAS CHECKED AND THE FILAMENT WAS CHECKED AND CALIBRATED. ALL THE POWER CAP CONNECTIONS WERE CHECKED. THE FILAMENT DRIVER BOARD WAS REPLACED AND THE BACKPLANE WAS REPLACED AND UPGRADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE AND INTERMITTENTLY THE SYS DISPLAYED A FILAMENT REGULATOR ERROR MESSAGE. NO PT INJURY WAS REPORTED.

    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