BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1232560 · Received November 13, 2008

    Report

    Report Number
    1720753-2008-27988
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 12, 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

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER. THE GE SERVICE REP WENT ONSITE FOR THE COMMUNICATION ERROR MESSAGE. HE WAS NOT ABLE TO DUPLICATE THE ERROR MESSAGE. SINCE THE SYSTEM SOFTWARE WAS LATER THAT -09, HE WAS NOT ABLE TO GET THE LOG FILES. THE REP CHECKED THE INTERCONNECT CABLE FOR DAMAGE AND FOR 5 VOLTS ON BOTH THE WORK STATION AND C-ARM. HE WAS NOT ABLE TO DUPLICATE WHAT COULD HAVE CAUSED THE COMMUNICATION ERROR. HE WAS TOLD THAT THE LASER AIMER WAS NOT WORKING. HE CHECKED THE BATTERIES IN THE LASER AIMER AND FOUND THAT THEY WERE INSTALLED INCORRECTLY. FUTURE RECOMMENDATION FOR THE SYSTEM WAS FOR AN SBC UPGRADE CONVERSION WHEREBY THE SYSTEM SOFTWARE IS UPGRADED TO VERSION 29 WHICH INCLUDES UPGRADING ALL THE BOARDS IN THE WORKSTATION AND THE GIB BOARD AND BACKPLANE IN THE C-ARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A COMMUNICATION ERROR AND THE BEAM LIGHT DOES NOT WORK. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1