BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 2000

    MDR report key: 1014260 · Received March 12, 2008

    Report

    Report Number
    1720753-2008-17909
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 18, 2008
    Report Date
    March 11, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE VOLTAGE WAS ADJUSTED 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 2000 SYSTEM WOULD NOT FLUORO DURING A CASE. THE SYSTEM WAS RE-BOOTED THEN IT HAD AN ERROR CODE MESSAGE. THE PT WAS MOVED TO ANOTHER ROOM AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 2000 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR