BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELSCINT VARICAM

    MDR report key: 518617 · Received February 2, 2004

    Report

    Report Number
    9613299-2004-00001
    Event Type
    Malfunction
    Date Received
    February 2, 2004
    Date of Event
    December 19, 2003
    Report Date
    January 29, 2004
    Manufacturer
    GE MEDICAL SYSTEMS F.I. HAIFA
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPANY RECEIVED A REPORT CONCERNING UNINTENDED DETECTOR HEAD MOTION AND FAILURE TO STOP THIS MOTION BY HAND MOTION CONTROLLER (RCU) AND PRESSURE SENSITIVE DEVICE (PSD). CASE OCCURRED AFTER ACQUISITION ERROR MESSAGE APPEARED ON OPERATOR CONSOLE DURING PT SCANNING. THE OPERATOR INITIATED COMPUTER RESET IN ORDER TO START NEW SCANNING PROCESS. PT WAS STILL ON BED AND DETECTOR HEADS WERE AT A 45-DEGREE ANGLE ABOVE PT. DURING COMPUTER BOOT UP ANOTHER OPERATOR MOVED THE DETECTOR HEADS IN A "RADIAL OUT" MOVEMENT. UPON COMPLETION OF THE OUT MOVEMENTS, WHILE OPERATOR HUNG THE RCU ON ITS HOLDER, BOTH HEADS STARTED TO MOVE TOWARDS PT WITHOUT ANY OPERATOR COMMAND. THE OPERATOR TRIED TO STOP HEAD MOVEMENTS, FIRST BY RCU AND LATER BY HITTING THE PSD. DETECTOR HEADS FAILED TO STOP AND THE OPERATOR RELEASED THE PT MANUALLY USING THE BED CLUTCH HANDLE. UPON PT RELEASE THE OPERATOR STOPPED THE HEAD MOTIONS BY PUSHING THE EMERGENCY SWITCH BUTTON. AFTER NEW SYSTEM BOOT UP THE OPERATOR CHECKED THE SYSTEM AND NO PROBLEMS WERE FOUND. THE PT WAS RESCANNED SUCCESSFULLY. NO INJURY WAS REPORTED OR ANY OTHER ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELSCINT VARICAM NUCLEAR MEDICINE KPS GE MEDICAL SYSTEMS F.I. HAIFA VARICAM *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR