BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 1760691 · Received July 14, 2010

    Report

    Report Number
    8020711-2010-00006
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 18, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    KPQ
    PMA / PMN Number
    K033339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFORMATION, VARIAN HAS BEEN ABLE TO CONFIRM THE USER'S ALLEGATION: FOLLOWING PLAN CREATION AT ACUITY, AN IMAGE IS ACQUIRED AND GRABBED TO CREATE A FIELD FROM PATIENT ANTERIOR TO POSTERIOR (E.G. AP FIELD, AP IMAGE). AN OUTLINE IS DRAWN ON THE ACQUIRED IMAGE BY THE PHYSICIAN, OUTLINING THE AREAS TO BE TREATED. THE MULTI LEAF COLLIMATOR IS ADDED AND FITTED TO THIS OUTLINE. IF THE USER CREATES AN OPPOSING FIELD (PA FIELD, PA IMAGE), THE MLC ARE NOT CORRECTLY OPPOSED (THE MLC ON THE PA FIELD ARE POSITIONED EXACTLY AS ON THE AP FIELD RATHER THAN IN A MIRRORED POSITION). IF THE USER DOES NOT NOTICE THE INCORRECT PLACEMENT OF THE MLC ON THE OPPOSED FIELD AND IF IT IS NOT CAUGHT DURING PLAN REVIEW OR APPROVAL FOR TREATMENT, THE PATIENT CAN BE TREATED WITH INCORRECTLY PLACED MLC ON THE OPPOSED FIELD. AN INTERNAL CORRECTIVE ACTION WAS INITIATED TO FURTHER EVALUATE ANY FUTURE DESIGN IMPROVEMENT. AS A RESULT, A FUTURE RELEASE OF THE ACUITY SOFTWARE WILL CONTAIN A CORRECTION. IN ORDER TO MITIGATE RECURRENCE OF THIS ISSUE FOR CURRENT ACUITY USERS, A CUSTOMER TECHNICAL BULLETIN (CTB) WILL BE PROVIDED TO FURTHER DESCRIBE THE BEHAVIOR AND INSTRUCT ON THE AVAILABLE WORKAROUND. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING TREATMENT PLANNING CREATION IN ACUITY, THE MULTI LEAF COLLIMATOR SHAPE FOR A BEAM CREATED USING THE COPY AND OPPOSE BEAM FUNCTION IS MIRRORED ON THE X-AXIS, INSTEAD OF THE Y-AXIS. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED, AS THIS EVENT WAS OBSERVED BY THE USER DURING TREATMENT PLANNING, AND THE PLAN WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY SIMULATOR KPQ VARIAN MEDICAL SYSTEMS H77-SIM

    Patients

    Seq Age Sex Outcome Treatment
    1