BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIEMENS BRAND NAME: ARTISTE MV

    MDR report key: 2050981 · Received March 30, 2011

    Report

    Report Number
    2910081-2011-00012
    Event Type
    Other
    Date Received
    March 30, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K072485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RISK ASSESSMENT INDICATES: SEVERITY: 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 WERE USED TO STOP THE UNINTENDED GANTRY MOTION. PROBABILITY: B (IMPROBABLE). REASON: ACCORDING TO THE USER MANUAL, THE THERAPIST MUST SUPERVISE THE PT TREATMENT AT ALL TIMES AND STOP ANY UNEXPECTED MOTION OF THE SYSTEM BEFORE THE PT IS INJURED BY MOVING PARTS. COMPONENT PARTS WERE RETURNED AND INVESTIGATED. AS A RESULT, IT HAS BEEN DETERMINED THAT A POWER OVERLOAD OCCURRED WITHIN THE DRIVE SIGNAL POWER LINE, CAUSING A POWER OUTPUT FAILURE. THIS CONDITION WOULD RESULT IN THE OBSERVED UNCOMMANDED GANTRY MOTION. A FINAL CORRECTIVE ACTION IS PENDING.

    Description of Event or Problem · 1

    A POTENTIAL PRODUCT ISSUE HAS BEEN IDENTIFIED WITH OUR ARTISTE MV LINEAR ACCELERATOR. IN THE ABUNDANCE OF CAUTION THIS ISSUE IS BEING REPORTED. IT WAS REPORTED THAT THERE WAS AN UNCOMMANDED MOTION OF THE DEVICE GANTRY. ON THIS DEVICE, THE GANTRY ROTATED IN A CLOCKWISE DIRECTION ABOUT 90 DEGREES AT A VERY SLOW SPEED (MUCH SLOWER THAN A NORMAL COMMANDED GANTRY MOTION) BEFORE THE THERAPIST WAS ABLE TO STOP IT MANUALLY BY TRIGGERING A MOTION STOP. THERE HAS BEEN NO MISTREATMENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1