BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS BRAND NAME: ARTISTE MV

    MDR report key: 1944764 · Received December 10, 2010

    Report

    Report Number
    2910081-2010-00050
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 3, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K072485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRELIMINARY RISK ASSESSMENT INDICATES: SEVERITY: 3 (CRITICAL). REASON: THERE HAS BEEN NO INJURY REPORTED. THE COMPLAINT BEHAVIOR MAY POTENTIALLY RESULT IN A SERIOUS INJURY. THERE ARE EMERGENCY OFF BUTTONS INSTALLED AND THEY WERE USED TO STOP THE UNINTENDED GANTRY MOTION. PROBABILITY: B (IMPROBABLE). REASON: ACCORDING TO THE USER MANUAL, THE THERAPIST MUST SUPERVISE THE PATIENT TREATMENT AT ALL TIMES AND STOP ANY UNEXPECTED MOTION OF THE SYSTEM BEFORE THE PATIENT 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. IT WAS REPORTED THAT THE MACHINE GANTRY MOVED WITHOUT COMMAND. A MOTION STOP SAFETY FEATURE WAS USED TO HALT THE ROTATION. PRELIMINARY INVESTIGATION REVEALED THAT A G41 PRINTED CIRCUIT BOARD ASSEMBLY SHORT CIRCUITED AND FAILED. NO INFORMATION WAS REPORTED THAT SUGGESTS A MISTREATMENT OR SERIOUS INJURY HAS OCCURRED.

    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