BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1040824 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21377
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 8, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE PS3 POWER SUPPLY, FILAMENT DRIVER BOARD, AND POWER MODULE 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

    IT WAS REPORTED THAT THE VERTICAL LIFT COLUMN ON THE 9800 SYSTEM WOULD NOT WORK AND THERE WAS A CHARGER FAILURE ERROR DURING A CASE. 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