BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS ARTISTE MV

    MDR report key: 1894784 · Received November 5, 2010

    Report

    Report Number
    2910081-2010-00044
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K072485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRELIMINARY RISK ASSESSMENT INDICATES: SEVERITY: PRELIMINARY 3 (CRITICAL). REASON: THERE HAS BEEN NO INJURY REPORTED. THE COMPLAINT BEHAVIOR MAY POTENTIALLY RESULT IN A SERIOUS INJURY. THE GANTRY WAS ROTATING SLOWLY. THERE ARE EMERGENCY-OFF BUTTONS INSTALLED AND THEY HAVE BEEN USED TO STOP THE UNINTENDED GANTRY MOTION. PROBABILITY: PRELIMINARY B (IMPROBABLE). REASON: ACCORDING TO THE USER MANUAL, THE THERAPIST MUST SUPERVISE THE PT TREATMENT ALL THE TIME AND STOP ANY UNEXPECTED MOTION OF THE SYSTEM BEFORE A PT IS INJURED BY MOVING PARTS. FINAL CORRECTIVE ACTION IS PENDING FURTHER INVESTIGATION. NO OTHER PRODUCTS ARE AFFECTED.

    Description of Event or Problem · 1

    A POTENTIAL PRODUCT ISSUE HAS BEEN REPORTED WITH OUR ARTISTE MV LINEAR ACCELERATOR. IN THE ABUNDANCE OF CAUTION THIS ISSUE IS BEING REPORTED. AN UNCOMMANDED MOTION OF THE GANTRY NOT STOPPED BY INTERLOCKS, WAS STOPPED BY THE MOTION STOP FEATURE. THE SITE REP REPORTED THAT DURING PT SETUP, THE GANTRY BEGAN TO CREEP IN THE CLOCKWISE DIRECTION. THE CONTROL CONSOLE WAS IN REMOTE MODE AND PT'S TREATMENT FIELD WAS DOWNLOADED. NO OPERATOR INTERVENTION WAS OCCURRING AT CONSOLE OR HAND CONTROL. THE MOTION HAD TO BE STOPPED WITH THE USE OF THE MOTION STOP BUTTON. THE MACHINE MONITOR SHOWS A COMMUNICATION ERROR AS WELL AS SEVERAL CONTROLLER 0 EVENTS ALL ASSOCIATED WITH END OF TRAVEL ERRORS INCLUDING GANTRY AXIS COLLIMATOR AXIS, Y1 AND Y2 AXIS. THE SITE REP REPORTS NO CONTROLLER OR COMMUNICATIONS I/L'S DISPLAY. NO INFO WAS REPORTED THAT SUGGESTS A MISTREATMENT OR SERIOUS INJURY HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS ARTISTE MV ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1