BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIEMENS BRAND NAME: ARTISTE MV

    MDR report key: 1413822 · Received July 6, 2009

    Report

    Report Number
    2910081-2009-00045
    Event Type
    Other
    Date Received
    July 6, 2009
    Date of Event
    June 17, 2009
    Report Date
    June 17, 2009
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K0724585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERITY: 3 (CRITICAL)- THERE MIGHT BE A SHIFT OF 10 MM IF THIS ISSUE IS NOT DETECTED IN MORE THAN ONE FRACTION. THIS MIGHT LEAD TO DOSE TO WRONG LOCATION. PROBABILITY: C (REMOTE)- 0.1-1 OCCURRENCES IN 1000 (0.01%-0.1%) PROBABLY WILL NOT OCCUR. LARGER SHIFTS ARE OBVIOUS FOR THE USER, WARNING MESSAGE APPEARS IN RTT, SELECTED ISOCENTER NAME IS DISPLAYED IN THE UI OF RTT. NO OTHER PRODUCTS ARE CONCERNED. CORRECTIVE ACTIONS: NO IMMEDIATE ACTIONS ARE REQUIRED. AN UPDATE OF RISK ANALYSIS IS TO BE EVALUATED AND CORRESPONDING ADEQUATE ACTIONS TO BE PERFORMED. CORRECTION OF THE FAILURE /INADEQUATE DESIGN WILL BE FIXED WITH NET VA 10C AND CORRESPONDING ADEQUATE ACTIONS IS TO BE PERFORMED BY THE PSG (MONITORED BY DCU). IN CASE FURTHER ACTIONS ARE REQUIRED BY THE FINAL INVESTIGATION THE RESPONSIBLE PSG (PROSPECTIVE DEVELOPMENT) /PQG (INSTALLED BASE) IS RESPONSIBLE TO SET UP AND DOCUMENT THESE ACCORDINGLY ON REQUEST OF DCU.

    Description of Event or Problem · 1

    A POTENTIAL PRODUCT ISSUE HAS BEEN REPORTED WITH OUR ARTISTE MV LINEAR ACCELERATOR. IN THE ABUNDANCE OF CAUTION THIS ISSUE IS BEING REPORTED. FOR A KONRAD PLAN, AT SELECTED THE WRONG REFERENCE POINT AS LOCKED PLANNING ISOCENTER. INSTEAD OF THE MARKED REFERENCE POINT POSITIONED AT THE ISOCENTER LOCATION, THE APPLICATION AUTOMATICALLY SELECTED ANOTHER REFERENCE POINT PRESENT IN THE DATASET. IT IS UNKNOWN IF THERE WAS ANY INJURY OR MISTREATMENT. THE ROOT CAUSE FOR THE PROBLEM IS THAT BEAM NAMES ARE DIFFERENT IN THE EXPORTED DICOM RT PLAN AND IN THE EXPORTED RTP FILE OF KONRAD. FOR THIS REASON, AT THE END OF THE FIRST TREATMENT, THE UPDATE OF BEAM ISOCENTERS IN THE LANTIS PLAN ON THE RTT WILL FAIL. NEVERTHELESS THE REFERENCE TO THE STRUCTURE SET WILL BE COPIED TO THE LANTIS PLAN. FOR THIS REASON, THE LANTIS PLAN WILL BE LOADABLE ON THE SECOND DAY OF TREATMENT, BUT THE BEAM ISOCENTER INFORMATION WILL NOT BE AVAILABLE. SO AT WILL EITHER SELECT A REFERENCE POINT BASED ON THE INFORMATION THAT IT WAS SELECTED AS "MARKER" IN VSIM, OR NOT AUTOMATICALLY SELECT ANY REFERENCE POINT AS ISOCENTER AUTOMATICALLY. IN BOTH CASES THE USER HAS TO MANUALLY SELECT THE CORRECT TREATMENT ISOCENTER TO GET THE CORRECT OFFSET.

    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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1