BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISTE MV SYSTEM

    MDR report key: 2853239 · Received November 30, 2012

    Report

    Report Number
    2910081-2012-10165
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K103606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS' INVESTIGATION INTO THE REPORTED INCIDENT IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SIEMENS WAS INFORMED ON (B)(4) 2012 THAT SEVERAL THERAPISTS WITNESSED A MULTILEAF COLLIMATOR (MLC) ERROR AND MLC FAILURE THAT OCCURRED DURING LPO-160 IMRT. REPORTEDLY, WHEN LAO-60 AND LAO-30 WAS RESUMED BUZZING NOISES WERE NOTICED DURING 6X IMRT HOWEVER, TREATMENT WAS COMPLETED. ALL WAS QUIET WHEN THE THERAPISTS ENTERED THE ROOM. THE BUZZING NOISE RETURNED WHEN THE GANTRY WAS ROTATING TO ZERO (0). WITNESSES OBSERVED BOTH BANKS AND ALL LEAVES SHAKING AND MOVING ABOUT 2-3 MM. THE CONSOLE WAS RESET, MLC INTERLOCKS REASSERTED AND THE SHAKING STOPPED. IN-HOUSE ENGINEERING CONFIRMED THAT D29 WAS UNREACHABLE. THE INTERLOCKS CLEARED AFTER MULTIPLE RESETS AND POWER CYCLING. THE MLC WAS RECALIBRATED, THE SYSTEM PASSED QA TESTS AND PATIENT TREATMENTS CONTINUED. THERE IS NO REPORT OF INJURY TO A PATIENT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 MULTILEAF COLLIMATOR 160