BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIEMENS BRAND NAME: ARTISTE MV

    MDR report key: 2222354 · Received August 15, 2011

    Report

    Report Number
    2910081-2011-00037
    Event Type
    Other
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K072485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY RISK ASSESSMENT INDICATES: SEVERITY: 3 (CRITICAL). THERE HAS BEEN NO MISTREATMENT OR INJURY REPORTED. THE SYSTEM WORKS AS SPECIFIED. THE PHYSICIST HAS TO ADAPT THE PLAN AND PERFORM THE MENTIONED CORRECTIONS OF THE DOSE BEFORE THE FIRST IRRADIATION IS POSSIBLE. WORST CASE: IF THE PHYSICIST MAKES A SEVERE MISTAKE WHEN MANUALLY ADAPTING THE MONITOR UNITS, IT IS POSSIBLE THAT AN INCORRECT DOSE WOULD BE DELIVERED FOR SEVERAL FRACTIONS. THIS COULD POTENTIALLY CAUSE A SERIOUS INJURY. PROBABILITY: B (IMPROBABLE) AFTER CHANGING THE PLAN, A NEW APPROVAL OF THE PLAN IS REQUIRED. IT IS VERY LIKELY, THAT A CONSIDERABLE DEVIATION FROM THE ORIGINALLY PLANNED DOSE WOULD BE RECOGNIZED AND CORRECTED BEFORE APPROVAL OF THE PLAN. NO OTHER PRODUCTS ARE CONCERNED AND FURTHER INVESTIGATION IS UNDERWAY FOR CAUSE DETERMINATION AND FINAL CORRECTIVE ACTION.

    Description of Event or Problem · 1

    A POTENTIAL PRODUCT ISSUE HAS BEEN IDENTIFIED WITH OUR ARTISTE LINEAR ACCELERATOR. IN THE ABUNDANCE OF CAUTION, THIS PRODUCT PROBLEM IS BEING REPORTED. CUSTOMER USES A TREATMENT PLANNING SYSTEM, WHICH GIVES FRACTIONAL MONITOR UNITS FOR VIRTUAL WEDGE TREATMENTS, ELECTRON TREATMENTS AND ARC TREATMENTS. HOWEVER, RTT 4.2 DOES NOT SUPPORT FRACTIONAL MONITOR UNITS FOR THOSE ABOVE MENTIONED TREATMENTS. CUSTOMER IS UNABLE TO USE INTEGER MONITOR UNITS BECAUSE THEY REQUIRE FRACTIONAL MONITOR UNITS FOR STEP-AND-SHOOT INTENSITY MODULATED RADIATION THERAPY PLANS (IMRT). ACCORDING TO THE CUSTOMER, THE TREATMENT PLANNING SYSTEM DOES NOT ALLOW FRACTIONAL MONITOR UNITS FOR IMRT PLANS AND INTEGER MONITOR UNITS FOR OTHER PLANS. AS A RESULT, THE PHYSICIST HAS TO MANUALLY ADAPT THE PLAN AND PERFORM CORRECTIONS OF THE DOSE BEFORE THE FIRST IRRADIATION OF A PATIENT.

    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.

    Patients

    Seq Age Sex Outcome Treatment
    1