BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1071051 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-22748
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 20, 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

    THE GE SERVICE REP INSPECTED, THE 2800 SYSTEM AND CONFIRMED TABLE COMMUNICATION FAILURE. CHECKED ALL CABLES/CONNECTORS AT TGI PCB, MOTRON PCB AND POWER DISTRIBUTION PCB, ALL OK. ALSO CHECKED 5V, 12V, 24V AT THE POWER DISTRIBUTION, TGI AND MOTRON, ALL WITHIN SPEC. FOUND THE MOTRON PCB CAUSING THE TABLE COMMUNICATION FAILURE. REPLACED THE MOTRON PCB, FIBER OPTIC CABLE AND PERFORMED ALL CALIBRATION PROCEDURES PER THE 2800 SERVICE MANUAL. TESTED SYSTEM USING ALL FUNCTIONS. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED COMMUNICATION ERRORS BETWEEN THE TABLE AND WORKSTATION. THE 2800 SYSTEM WAS DISPLAYING TABLE COMMUNICATION FAILURE AT BOOT UP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1