BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 7600

    MDR report key: 1113003 · Received August 15, 2008

    Report

    Report Number
    9680959-2008-00068
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 23, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 MONITOR ON THE 7600 SYSTEM WOULD FLICKER AND NOT WORK PROPERLY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 7600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1