BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY MX

    MDR report key: 1964110 · Received December 20, 2010

    Report

    Report Number
    2916710-2010-00145
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K092871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NO INJURY REPORTED IN THIS CASE, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE. A PRODUCT NOTIFICATION LETTER WILL BE SENT TO AFFECTED CUSTOMERS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO FOLLOW-UP REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    THREE TIMES SINCE THIS MACHINE WENT CLINICAL, WHEN WE HAVE HAD TO INITIALIZE THE PU ARMS DUE TO TAKING THE MACHINE DOWN, THE KVD ARM FAILED INITIALIZATION WITH A FAULT OF 911252 EACH TIME, AND REQUIRED AN AXIS CALIBRATION. DURING TROUBLESHOOTING THIS PROBLEM IT WAS DETERMINED THAT THE WRIST PRIMARY ENCODER WAS LOOSE AND WAS CHANGING POSITION RELATIVE TO THE AXIS. THIS ISSUE WAS FOUND DURING SERVICE. NO REPORT OF PATIENT INJURY AND/OR PATIENT DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY MX ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS H19 - TRUE BEAM

    Patients

    Seq Age Sex Outcome Treatment
    1