BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 8800

    MDR report key: 1112965 · Received August 15, 2008

    Report

    Report Number
    9617766-2008-01085
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 23, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED WHEN ADD'L DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 8800 SYSTEM SHUT DOWN DURING A CASE. THE 8800 SYSTEM HAD TO BE REBOOTED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1