BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC 600 CD

    MDR report key: 737704 · Received July 6, 2006

    Report

    Report Number
    2914292-2006-00024
    Event Type
    Malfunction
    Date Received
    July 6, 2006
    Date of Event
    March 4, 2006
    Report Date
    June 8, 2006
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS DETERMINED THAT THE CAUSE OF THE UNWANTED MOTION PROBLEM IS ANY POTENTIAL LOSS OF REFERENCE VOLTAGE TO THE PENDANT FIRMWARE. IN THESE CIRCUMSTANCES, THE PENDANT WILL PRODUCE A SIGNAL EQUIVALENT TO A FULL THUMBWHEEL DEFLECTION. ONE POTENTIAL CAUSE OF A LOSS OF REFERENCE VOLTAGE IS A TRANSIENT FAILURE OF THE PENDANT CABLE, WHICH COULD THEN RESULT IN UNWANTED DRIVE COMMANDS WHEN THE MEB'S ARE ENABLED. A CORRECTION TO THIS ANOMALY HAS BEEN DEVELOPED THAT WILL EFFECTIVELY PREVENT FURTHER OCCURRENCES OF UNWANTED CLINAC MOTIONS DUE TO PENDANT FIRMWARE FAILURES. VARIAN'S ORIGINAL RISK ASSESSMENT DETERMINED THAT, DUE TO MULTIPLE MITIGATING FACTORS, SUCH AS RELEASE OF THE MEB'S OR THE CLOSE AVAILABILITY OF EMERGENCY OFF BUTTONS, IF THE INCIDENT WERE TO RECUR, IT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH. HOWEVER, A QUALITY PROCESS REVIEW DETERMINED THAT, BECAUSE OF THE SEVERE WORST-CASE SCENARIO, AN MDR WAS APPROPRIATE. A PNL HAS BEEN SENT TO THE AFFECTED CUSTOMERS. THIS IS AN EQUIPMENT CORRECTIVE ACTION, AS INDICATED ABOVE, WHICH WILL BE TAKEN IN THE FIELD. ALL CORRECTIVE ACTIONS WILL BE REPORTED UNDER THE GUIDELINE 21 CFR 806.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNEXPECTED MOVEMENT OF THE COLLIMATOR, GANTRY, AND COUCH DURING USE OF THE CLINAC AUTO SET-UP MODE. THE MOVEMENT STOPPED WHEN THE MOTION ENABLE BARS (MEB) WAS RELEASED. AFTER THE CUSTOMER RECEIVED THE PRODUCT NOTIFICATION LETTER (PNL) NOTIFYING THEM OF THIS ISSUE AND THAT IT WILL BE CORRECTED, THE CUSTOMER REPORTED WITNESSING THE UNEXPECTED MOVEMENTS ON THE FOLLOWING DATES; 2004, 2006, AND 2006. NO PATIENT WAS INJURED DURING THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC 600 CD LINEAR ACCELERATOR IYE 18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other