BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINAC

    MDR report key: 841941 · Received April 13, 2007

    Report

    Report Number
    2914292-2007-00020
    Event Type
    Other
    Date Received
    April 13, 2007
    Date of Event
    February 16, 2007
    Report Date
    February 16, 2007
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYG
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT WHEN THE MACHINE WAS FIRST ACCEPTED IN MARCH OF 2005, IT HAD COUCH ROTATION SCALE (IEC601). IN SEPTEMBER OF 2005, A VARIAN FIELD ENGINEER CALIBRATED THE COUCH ROTATION SCALE FROM IEC601 TO IEC1217. THE TREATMENT PLANS AND ACTUAL PLANS OF THE 5 PATIENT'S REPORTED BY THE CUSTOMER TO BE MISTREATED WERE REQUESTED BY VARIAN MEDICAL SYSTEMS, BUT THE CUSTOMER HAS REFUSED TO SEND DETAILED INFO ABOUT THE PATIENT'S. THE FIELD SERVICE REP WAS NOTIFIED OF THIS INSTALLATION ERROR AND HAS BEEN RE-TRAINED. THE FIELD SERVICE ENGINEER INSTALLED THE CORRECT COUCH ROTATION SCALE.

    Description of Event or Problem · 1

    IN 2007, THE CUSTOMER REPORTED TO A VARIAN FIELD ENGINEER THAT THE COUCH ROTATION MOVES INCORRECTLY WHEN HE TRIED TO MOVE THE COUCH ROTATION WITH AUTO SET UP. THE CUSTOMER REPORTED TO VARIAN THAT MOST ALL PATIENT'S THAT HAVE BEEN TREATED ON 0 DEGREE (I.E. THE COUCH ROTATION ANGLE IS THE SAME IN BOTH IEC601 AND IEC1217) OVER THE PERIOD FROM 2005 TO 2007. THERE ARE 5 PATIENT'S WHO RECEIVED AN INCORRECT DOSE. FOUR PATIENT'S OUT OF FIVE PT'S WERE TREATED WITH WHOLE-BRAIN IRRADIATION AND ONE PT WAS TREATED WITH BREAST CANCER. VARIAN WAS INFORMED BY THE DOCTOR THAT THERE PROBABLY WAS NO SERIOUS INJURY IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC LINEAR ACCELARATOR IYG VARIAN MEDICAL SYSTEMS 2100 C/D *

    Patients

    Seq Age Sex Outcome Treatment
    1 *