BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2500

    MDR report key: 996338 · Received February 11, 2008

    Report

    Report Number
    1720753-2008-01285
    Event Type
    Malfunction
    Date Received
    February 11, 2008
    Date of Event
    January 4, 2008
    Report Date
    February 11, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP DUPLICATED TABLE ERROR PROBLEM, BUT COULD NOT DUPLICATE UNCOMMANDED FLUORO - ORDERED PART NUMBER 00-871630-01 CONTROL PANEL CABLE. THIS PART NO LONGER AVAILABLE FROM GEHC OEC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO FILMER OPERATION, TABLE NOT READY ERROR INTERMITTENTLY APPEARING, AND UNCOMMANDED FLUORO. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2500 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1