BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS : ARTISTE MV

    MDR report key: 1793928 · Received July 30, 2010

    Report

    Report Number
    2910081-2010-00029
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    June 15, 2010
    Report Date
    July 8, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K072485
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRELIMINARY RISK ASSESSMENT INDICATES: SEVERITY: 3 (CRITICAL). THE COMPLAINT BEHAVIOR MAY POTENTIALLY RESULT IN A SERIOUS INJURY. PROBABILITY: B (IMPROBABLE). THERE ARE SEVERAL EMERGENCY STOP BUTTONS TO INTERRUPT MOVEMENTS. THE 550 TXT TABLE ASSOCIATED WITH THE ARTISTE IS IDENTIFIED AS FOLLOWS: CATALOG NUMBER 07346534. SERIAL NUMBER (B)(4). PMA/510(K) NUMBER K050422. NO OTHER PRODUCTS ARE AFFECTED.

    Description of Event or Problem · 1

    A POTENTIAL PRODUCT ISSUE HAS BEEN REPORTED INTERNALLY WITH OUR THE 550 TXT TABLE ASSOCIATED WITH OUR ARTISTE LINEAR ACCELERATOR. IN THE ABUNDANCE OF CAUTION THIS ISSUE IS BEING REPORTED. THE TXT 550 TABLE MOVED WITHOUT COMMAND DURING AN IMRT/AFS TREATMENT. THE MOVEMENT FIRST OCCURRED APPROX 1 MONT AGO AND ONLY WITH THE SAME PT AND NO INTERLOCK OCCURRED. AS A RESULT, THE SEQUENCE HAD TO BE STOPPED AND THE PT REPOSITIONED MANUALLY. CIRCUMSTANCES: AP/PA TREATMENT AUTO SEQUENCE SET UP. TABLE MOVED UP IN ¿PAUSE¿ STATE APPROX. 8 CM TWO TIMES AND ONCE LONGITUDINALLY OUT BY APPROX 1 CM. CORRECTIVE ACTION DECISION IS PENDING FINAL INVESTIGATION RESULTS.

    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