BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4D INTEGRATED TREATMENT CONSOLE

    MDR report key: 1700356 · Received May 21, 2010

    Report

    Report Number
    2916710-2010-00055
    Event Type
    Malfunction
    Date Received
    May 21, 2010
    Date of Event
    April 7, 2010
    Report Date
    April 7, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K050479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INITIAL REPORT, VARIAN'S MEDICAL ADVISOR HAS IDENTIFIED THAT THE TOTAL COURSE WAS 40 GY AND THE PLANNED DOSE FOR THAT FIELD WAS 1.3788 GY. THE MISSING WEDGE CAUSED AN ERROR OF 0.506 CGY, WHICH IS NOT CONSIDERED SIGNIFICANT AND WELL WITHIN THE TOLERANCE LIMITS. ALTHOUGH THERE WAS NO INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A MALFUNCTION IN THE DEVICE WHICH, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN TRYING TO CLOSE THE PATIENT AFTER TREATMENT, A SESSION SAVE ERROR MESSAGE DISPLAYED REFERRING TO A WEDGE ERROR. IT APPEARED THAT THE EDW (ENHANCED DYNAMIC WEDGE) DID NOT DELIVER AND AN OPEN FIELD WAS DELIVERED ON THE MEDIAL FIELD. THE PLAN WAS EXPORTED FROM RT CHART AFTER THE EVENT AND CONTAINED WEDGES ON BOTH FIELDS. HOWEVER, WHEN LOOKING AT THE VERSION OF THE DCM PLAN FILE EXPORTED FROM THE 4DTC (TREATMENT CONSOLE) JUST AFTER THE EVENT, THE LEFT MEDIAL FIELD WAS MISSING ITS EDW. THE ERROR WAS BROUGHT TO THE PHYSICIST'S ATTENTION WHEN THE RADIOGRAPHERS TRIED TO CLOSE THE PATIENT FOLLOWING TREATMENT AND THE TREATMENT HISTORIES WOULD NOT SAVE TO THE DATABASE. DUE TO THE MISSING EDW, THERE WAS VARIANCE IN THE PATIENT'S RADIATION PRESCRIPTION FOR THAT DAY. NO FURTHER PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4D INTEGRATED TREATMENT CONSOLE LINEAR ACCELERATOR SOFTWARE IYE VARIAN MEDICAL SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1