BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 2800

    MDR report key: 1071160 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-23100
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 12, 2008
    Report Date
    July 1, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. 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 X-RAY BUTTON ON THE 2800 SYSTEM WOULD NOT WORK DURING A CASE. THE SYSTEM WAS RESET AND THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1