BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOR IMPRESSION PLUS SYSTEM

    MDR report key: 2501297 · Received March 19, 2012

    Report

    Report Number
    2910081-2012-00020
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 17, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC. - RADIATION ONCOLOGY
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS BECAME AWARE OF THE REPORTED INCIDENT ON (B)(4) 2012. SIEMENS INVESTIGATION INTO THE REPORTED INCIDENT REVEALS THAT SIEMENS LINAC AND RTT SYSTEMS WORKS AS SPECIFIED. HOWEVER, INVESTIGATION OF DMIP LOG (B)(6) 2012, FOR THE PT ALSO REVEALS THAT THE TREATMENT BEAMS THAT WERE SELECTED IN AUTO SEQUENCE HAVE DIFFERENT PLANNED TABLE VALUES. THESE DIFFERENT TABLE VALUES IN THE TREATMENT PLAN CAUSED THE UNEXPECTED TABLE MOVEMENT. THE USE MANUAL CONTAINS A WARNING ABOUT OVERRIDING OUT-OF-TOLERANCE PARAMETERS AND ASKS THE USER TO ALWAYS MONITOR THE DELIVERY OF A FRACTION GROUP THAT CONTAINS MORE THAN ONE BEAM CAREFULLY. THE TABLE POSITION IS DISPLAYED AT THE USER INTERFACE. IT IS HIGHLIGHTED IN YELLOW BEFORE AND DURING THE TABLE MOVEMENT UNTIL IT HAS REACHED ITS TARGET POSITION. THUS, THE USER IS ABLE TO RECOGNIZE UNINTENDED TABLE MOVEMENTS IN ADVANCE, EVEN IF THESE ARE SMALL. THERE ARE BUTTONS INSTALLED FOR EMERGENCY POWER OFF, WHICH MAY BE USED TO STOP TREATMENT AND ALL MOVEMENT. THE CUSTOMER PURCHASED THE MOSAIQ SYSTEM FOR A THIRD PARTY VENDOR THAT PROVIDED MOSAIQ TRAINING ON COUCH VALUES TO RADIATION THERAPISTS AND DOSIMETRISTS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED ON (B)(4) 2012 THAT THE CUSTOMER EXPERIENCED AN UNEXPECTED TABLE MOVEMENT, AND THAT THE TABLE HAD AUTOMATICALLY DRIVEN IN TOWARD THE GANTRY IN THE LONGITUDINAL DIMENSION. REPORTEDLY, THE CUSTOMER STATED, "THE CLINICAL RESULT OF THIS IS THAT THE COUCH MOVED IN TOWARDS THE GANTRY 50 CM, AND INSTEAD OF TREATING THEIR INTENDED SITE (HEAD AND NECK), THEY DELIVERED 155 CGY TO THE PT'S SMALL INTESTINE." THERE IS NO INFO AS TO THE PT'S STATUS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOR IMPRESSION PLUS SYSTEM ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC. - RADIATION ONCOLOGY 05857912 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SWV 4.2 108, 56302| MOSAIQ SWV 2.2| RTT