BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC IX

    MDR report key: 2507042 · Received March 20, 2012

    Report

    Report Number
    2916710-2012-00012
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    January 20, 2012
    Report Date
    February 20, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K070094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMEDIATE CORRECTION: THE VARIAN SERVICE REP DETERMINED THAT THE WRONG JAW SETTINGS WERE DUE TO RESISTANCE IN AN ELECTRICAL CABLE. THE FAILED CABLE WAS REPLACED. ANALYSIS: THE ERROR WAS NOT DETECTED BY THE C-SERIES CONSOLE BECAUSE THE REFERENCE VOLTAGES FOR BOTH THE PRIMARY AND SECONDARY READOUT POTENTIOMETERS GO THROUGH THE SAME WIRES. THE FAILED CABLE AFFECTED BOTH THE PRIMARY AND SECONDARY READOUTS EQUALLY, SO THEY WERE OFF BY THE SAME AMOUNT AND NO INTERLOCK WAS GENERATED. IN THIS SITUATION, WHEN THE REFERENCE VOLTAGE DROPS, THE ACTUAL JAW POSITION MAY DIFFER FROM THE INTENDED JAW POSITION; THE DIGITAL DISPLAY WILL INDICATE ONLY THE INTENDED JAW POSITION AND WILL NOT ACCURATELY SHOW THE ACTUAL JAW POSITION. ANY JAW COULD BE AFFECTED AND COULD RESULT IN UNPLANNED DOSE TO NORMAL TISSUE AND/OR CRITICAL STRUCTURES. ADDITIONALLY, THE GANTRY POSITION, COLLIMATOR ROTATION AND COUCH AXES COULD BE AFFECTED AND THE ACTUAL POSITION MAY DIFFER FROM THE INTENDED POSITION. A PRODUCT NOTIFICATION LETTER HAS BEEN SENT TO AFFECTED CUSTOMERS. THIS PROBLEM WAS PREVIOUSLY REPORTED IN MDR 2916710-2011-00142, ((B)(4)). ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER BELIEVES THAT A PT WAS PROBABLY TREATED WITH THE JAWS ALMOST CLOSED, DESPITE THE MACHINE FUNCTIONING AS IF THE JAWS WERE IN THE CORRECT POSITION. THE CUSTOMER WAS ABLE TO REPRODUCE THE ERROR BY TURNING THE GANTRY TO CERTAIN ANGLES. AT CERTAIN GANTRY ANGLES, THE VOLTAGE THAT GOES TO THE POTENTIOMETERS DECREASED. THE RESULT WAS THAT ALL POTENTIOMETER VALUES WERE LOWER. THIS AFFECTED ALL OF THE POTENTIOMETERS IN SUCH A WAY THAT THERE WAS NO INTERLOCK AS A RESULT. NO REPORT OF INJURY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC IX ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H29

    Patients

    Seq Age Sex Outcome Treatment
    1