BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 2231341 · Received July 26, 2011

    Report

    Report Number
    8020711-2011-00010
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS UK LTD.
    Product Code
    KPQ
    PMA / PMN Number
    K023052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE HAVE BEEN REPORTS OF THIS ISSUE IN THE ACUITY PRODUCT LINE, THE AVAILABLE INFO SUGGESTS IT MAY BE POSSIBLE TO REPRODUCE THIS OR SIMILAR ISSUE IN ACUITY. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE SERIOUS INJURY. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    VARIAN INITIATED EVAL OF THE ACUITY, FOR THE POSSIBILITY OF THE WRONG ENERGY BEING USED FOR DOSE CALCULATION AS REPORTED IN ECLIPSE VERSION 10. IT HAS BEEN PREVIOUSLY REPORTED THAT WITH ECLIPSE VERSION 10, THAT A COPY, PASTE AND RECALCULATION CAN BE PERFORMED FOR A PT PLAN AND THAT INCORRECT BEAM ENERGY IS USED FOR THE BEAMS IN THE COPIED AND PASTE PLAN. IF THE USER EDITS THE ENERGY IN THE COPIED PLAN THEN REVERTS, WITHOUT USER INTERVENTION, BACK TO THE ENERGY IN THE ORIGINAL PLAN; THE CALCULATED MU AND ISODOSES ARE NOT INVALIDATE. THE ROOT CAUSE OF THIS ISSUE IN THE ECLIPSE PRODUCT HAS BEEN TRACED TO CORRUPT HANDLING OF DATABASE CACHE. IT HAS BEEN REQUESTED BY VARIAN ENGINEERING, THAT THIS ISSUE, REPORTED FOR THE ECLIPSE PRODUCTS, BE EVALUATED TO SEE IF THE SAME (OR SIMILAR) RISK APPLIES TO THE ACUITY PRODUCTS. THERE HAVE BEEN NO OCCURRENCES OF THIS ISSUE REPORTED IN THE ACUITY PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY ACCELERATOR, LINEAR, MEDICAL KPQ VARIAN MEDICAL SYSTEMS UK LTD. H77

    Patients

    Seq Age Sex Outcome Treatment
    1