BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS BRAND NAME: ARTISTE MV

    MDR report key: 1830169 · Received September 1, 2010

    Report

    Report Number
    2910081-2010-00034
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 12, 2010
    Report Date
    August 11, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K072485
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRELIMINARY RISK ASSESSMENT INDICATES: SEVERITY 3 (SERIOUS INJURY): THE MAGNITUDE OF THE SHIFT IS PROPORTIONAL TO THE ASPECT RATIO OF THE IMAGE. IF WRONG POSITION IS APPLIED SEVERAL TIMES IN A ROW TO A CRITICAL ORGAN, THIS COULD RESULT IN SERIOUS INJURY. PROBABILITY B (IMPROBABLE): THE SHIFT IN THE CONTOURS ON THE REFERENCE IMAGE (DRR) WOULD NOT RESULT IN A MISTREATMENT BECAUSE THE USER IS TRAINED TO USE THE INTERACTIVE SHIFT TOOL TO MATCH THE CONTOURS ON THE DRR WITH THE PORTAL IMAGE. THEREFORE, REGARDLESS OF WHERE THE CONTOUR IS, THE USER WILL MATCH THE PORTAL IMAGE WITH THE REFERENCE IMAGE AND THE OFFSET CALCULATION WOULD BE CORRECT. THE USER MAY WONDER WHY THE CONTOURS ARE NOT IN AN EXPECTED POSITION, BUT THE USER WOULD STILL MATCH THESE CONTOURS WITH ANATOMY ON THE PORTAL IMAGE. THE SHIFT IS ALSO DISPLAYED ON THE REFERENCE IMAGE WHICH WILL CONTRIBUTE TO THE DETECTING ABILITY OF THE PROBLEM FOR THE LARGE SHIFTS. NO OTHER PRODUCTS ARE AFFECTED.

    Description of Event or Problem · 1

    A POTENTIAL PRODUCT ISSUE HAS BEEN REPORTED WITH OUR ARTISTE LINEAR ACCELERATOR. IN THE ABUNDANCE OF CAUTION THIS ISSUE IS BEING REPORTED. AFTER A COUPLE OF DAYS AFTER THE PT STARTED TREATMENT, THE CONTOURS ON THE DRR'S APPEAR TO BE SHIFTED. PT WAS IMAGED ON THE FOLLOWING DATES. THE OBSERVATION THEY HAD LISTED WITH THEIR NOTES ARE WITHIN THE ( ). ON (B)(6) - 000, 001 (UNABLE TO ASSOCIATE REF IMAGE WITH 000, IMAGE ASSOCIATED MANUALLY WITH 001). ON (B)(6) - 001, 1-AP (REF IMAGE WITH 001 DID NOT SHOW UP, IMAGE MANUALLY ASSOCIATED WITH 1-AP). ON (B)(6) - 001, 1-AP (REF IMAGE WITH 001 SHOWS UP WITH NO USER INTERVENTION, 1-AP LOADS WITH REF IMAGE). ON (B)(6) 001, 1-AP (CONTOURS THAT WERE PREVIOUSLY DRAWN ON DRR CORRESPONDING TO 001 IS SHIFTED). CORRECTIVE ACTION DECISION IS PENDING FINAL INVESTIGATION RESULTS.

    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