BEUDAMED
    FDA Adverse Event Death Summary report: N

    GE OEC 9400

    MDR report key: 885261 · Received July 26, 2007

    Report

    Report Number
    1720753-2007-03535
    Event Type
    Death
    Date Received
    July 26, 2007
    Date of Event
    July 1, 2007
    Report Date
    July 26, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    PMA / PMN Number
    K864837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SYSTEM IS PAST THE END OF LIFE CYCLE AND IS OBSOLETE. NO PARTS FOR REPAIR ARE AVAILABLE. ALL CUSTOMERS WITH OEC SERIES 9400 SYSTEMS WERE NOTIFIED OF SYSTEM END OF LIFE EFFECTIVE DECEMBER 31, 2003. A GE OEC SERVICE REPRESENTATIVE INVESTIGATED THE ISSUE AND INFORMED THE CUSTOMER THAT THE BATTERIES WERE THE LIKELY CAUSE OF THE IMAGE QUALITY ISSUE NOTED FOR THE SYSTEM BEING REMOVED DURING THE PROCEDURE. BATTERIES FOR THIS SYSTEM ARE NO LONGER AVAILABLE AS THE SYSTEM IS OBSOLETE, AND SERVICE COULD NOT BE PERFORMED. THE SYSTEM, EVEN IF OBSOLETE, REQUIRES THAT IT BE PLUGGED IN, IF IT IS NOT USED, OR IT IS STORED FOR A PROLONGED PERIOD OF TIME (3 MONTHS OR LONGER). IT IS INDICATED, IN THE SERVICE REPORT, THAT THE SYSTEM MAY HAVE BEEN STORED FOR AN EXTENDED PERIOD OF TIME, WITHOUT BEING PLUGGED IN, AND THIS WOULD NEGATIVELY AFFECT THE BATTERIES AND SYSTEM PERFORMANCE, INCLUDING IMAGE QUALITY.

    Description of Event or Problem · 1

    THE GE OEC 9400 FLUOROSCOPY SYSTEM WAS REPORTED TO HAVE POOR IMAGE QUALITY. THE SYSTEM WAS BEING USED FOR A TRANSCUTANEOUS PACEMAKER INSERTION IN THE FACILITY INTENSIVE CARE UNIT. IT WAS REPORTED THAT THE PACEMAKER LEAD COULD NOT BE VISUALIZED BY THIS SYSTEM AND IT WAS REMOVED FROM THE BEDSIDE FOR REPLACEMENT WITH ANOTHER C-ARM TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PT EXPIRED PRIOR TO THE REPLACEMENT C-ARM ARRIVAL IN THE INTENSIVE CARE UNIT. REPORTED ISSUE FROM FACILITY: POOR IMAGE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9400 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC GE OEC 9400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death