BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS ECAT

    MDR report key: 191501 · Received October 8, 1998

    Report

    Report Number
    1034973-1998-00001
    Event Type
    Malfunction
    Date Received
    October 8, 1998
    Date of Event
    September 16, 1998
    Report Date
    September 16, 1998
    Manufacturer
    CTI PET SYSTEMS, INC.
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM OPERATOR WAS POSITIONING A PT INTO THE SCANNER GANTRY FOR A PET STUDY USING THE GANTRY FRONT PANEL CONTROL BUTTONS TO POSITION THE PT HANDLING SYSTEM (PHS) BED. THE OPERATOR THEN REPORTEDLY LEFT THE ROOM TO CHECK FOR CORRECT PT POSITIONING ON THE SYSTEM COMPUTER. AT THAT TIME THE OPERATOR REPORTED HEARING A NOISE COMING FROM THE SCANNER ROOM. SHE REPORTEDLY RUSHED BACK INTO THE SCANNER ROOM AND SAW THE BED WAS UNEXPECTEDLY MOVING DOWNWARD WITHOUT THE OPERATOR COMMANDING BED DOWN MOTION. THE OPERATOR SAID SHE PRESSED THE EMERGENCY STOP BUTTON ON THE GANTRY BUT CLAIMS THE BUTTON DID NOT WORK AND THE BED CONTINUED DOWNWARD TO ITS LOWER TRAVEL LIMIT. IT WAS REPORTED THAT AS THE BED DESCENDED THE HEAD END OF THE PT PALLET APPARENTLY HUNG UP ON THE EDGE OF THE SCANNER PORT AND THEN SUDDENLY DROPPED BACK ONTO THE PHS, STARTLING THE PT AND CAUSING HER SOME DISCOMFORT. A SECOND MED TECH THEN CAME INTO THE ROOM AND TRIED TO MOVE THE PHS BED AWAY FROM THE GANTRY USING THE HORIZONTAL CONTROL BUTTONS. THE BED THEN REPORTEDLY STARTED TO MOVE BACK UPWARD AT WHICH TIME MOVEMENT WAS STOPPED BY THE SECOND TECH PRESSING THE EMERGENCY STOP BUTTON. THE PT WAS REMOVED FROM THE SCANNER BED BY THE MED TECH AND DID NOT APPEAR TO BE INJURED. SOMETIME AFTER THE EVENT OCCURRED, THE PT REPORTED TO THE HOSPITAL THAT SHE WAS EXPERIENCING BACK AND NECK PAIN AS A RESULT OF THE EVENT. FOLLOWING THIS INCIDENT, TWO LOCAL SIEMENS FILED ENGINEERS RESPONDED TO A REQUEST FOR SERVICE BY THIS CUSTOMER. PROBLEM DIAGNOSIS OF THE SCANNER'S OPERATION BY THE SERVICE ENGINEERS LED TO THE REPLACEMENT OF THE PHS BED CONTROLLER CHASSIS WHICH CORRECTED THE VERTICAL MOTION CONTROL MALFUNCTION. A CTI FACTORY SUPPORT ENGINEER ALSO VISITED THE SITE AND FOUND ADDITIONAL PROBLEMS WITH THE HORIZONTAL POSITION ENCODER AND WITH CONNECTIONS TO THE HORIZONTAL MOTOR AND ENCODER. REPAIR OF THESE TWO FAULTS CORRECTED THE PHS HORIZONTAL MOTION CONTROL PROBLEMS. THE PHS VERTICAL AND HORIZONTAL MOTIONS WERE REPEATEDLY CYCLED TO VERIFY PROPER OPERATION. THE SYSTEM'S EMERGENCY STOP CAPABILITY WAS TESTED EXTENSIVELY WITH NO FAILURE OF THIS FUNCTION BEING OBSERVED. AFTER BEING REPAIRED AND TESTED, THE SYSTEM WAS DEEMED TO BE OPERATING WITHIN ITS DESIGN PARAMETERS AND WAS SUBSEQUENTLY RETURNED TO OPERATIONAL STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS ECAT POSITRON EMISSION TOMOGRAPHY (PET) SCANNER KPS CTI PET SYSTEMS, INC. 953 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN