BEUDAMED
    FDA Adverse Event Death Summary report: N

    GE OEC 9800

    MDR report key: 1333399 · Received March 3, 2009

    Report

    Report Number
    1720753-2009-01888
    Event Type
    Death
    Date Received
    March 3, 2009
    Report Date
    March 3, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM IS UNDER THIRD PARTY CONTRACT, AND THE ISSUE WAS NOT REPORTED TO GE OEC UNTIL 02/26/2009. THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED WHEN ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE YEAR AGO, THE 9800 SYSTEM LOCKED UP PRIOR TO A AORTIC STENT PLACEMENT CASE. THE PT CODED PRIOR TO THE PROCEDURE. IT WAS REPORTED THE PT DIED, DATE UNKNOWN AND NO PT INFORMATION WAS GIVEN.

    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 Death