BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISTE MV SYSTEM

    MDR report key: 2449741 · Received February 8, 2012

    Report

    Report Number
    2910081-2012-00010
    Event Type
    Malfunction
    Date Received
    February 8, 2012
    Date of Event
    December 27, 2011
    Report Date
    January 10, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K072485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE SYSTEM LOG FILES ASSOCIATED WITH THE REPORTED ISSUE SHOWED THAT THE USER OVERRODE THE SEQUENCE FOR BED POSITIONING FOR TREATMENT. ACCORDING TO THE OVERRIDE CONCEPT FOR THE REFERENCED SOFTWARE SYSTEM, IN-TOLERANCE TABLE SHIFTS ARE APPLIED TO ALL SELECTED BEAMS IN AUTO SEQUENCE. FIELD 2 WAS SENT TO THE CONTROL CONSOLE WITH OVERRIDDEN LATERAL AND VERTICAL TABLE PARAMETERS AND UNCHANGED LONGITUDINAL. OUT-OF-TOLERANCE TABLE SHIFTS ARE APPLIED TO ALL CONSECUTIVE BEAMS IN THE TREATMENT SEQUENCE ONLY IF THE USER ACCEPTS IT IN THE APPROPRIATE DIALOG WINDOW BY CLICKING ON THE 'YES' BUTTON. THIS DIALOG ALWAYS APPEARS AFTER THE USER ACCEPTS THE OVERRIDES. IF THE USER SELECTS 'NO' IN THIS DIALOG, THE OVERRIDDEN TABLE VALUE (S) WILL BE APPLIED TO THE CURRENT BEAM ONLY. FROM (B)(4) POINT OF VIEW, THERE IS NO WRONG SYSTEM BEHAVIOR IN THE LOGS. THE OBSERVED BEHAVIOR OF THE SYSTEM IS CONSISTENT WITH THE OVERRIDE CONCEPT. (B)(6).

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED ON (B)(4) 2012 THAT UNWANTED LINAC BED MOVEMENT OCCURRED DURING TREATMENT OF A PT. REPORTEDLY, THE PT'S BREAST WAS THE AREA OF TREATMENT. THE FIELDS WERE LOADED IN A SEQUENCE, AND THE BED MOVED BETWEEN TWO MEDIAL TANGENTIAL BEAMS. THE BED MOVEMENT WAS INTERRUPTED BY THE USER DISCONTINUING THE TREATMENT. THE INFERIOR BED MOVEMENT WAS MEASURED TO BE 27CM IN THIS INSTANCE. HOWEVER, IT WAS OBSERVED THAT SUCH OCCURRENCES SEEM TO BE RANDOM. THE BED COORDINATES CHANGES TO 0,0,0 BETWEEN TWO IDENTICAL BEAMS, THE ONLY DIFFERENCE BEING THE CHANGING OF BEAM ENERGY FROM 6 TO 15 MV. THE REPORTED ISSUE OCCURRED IN SOUTH AFRICA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTISTE MV SYSTEM ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC. 08139789 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 SYNGO RT THERAPIST CONNECT/MOSAIQ,| MODEL# 08168754, SERIAL# (B)(4)