BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVALIS TX

    MDR report key: 2029306 · Received February 18, 2011

    Report

    Report Number
    2916710-2011-00012
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    November 9, 2010
    Report Date
    January 20, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K070094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEWED MANUFACTURING AND SERVICE DOCUMENTATION. A VIDEO OF THE HOSE CONFIGURATION PROVIDED AND DISCUSSIONS, POINT TO AN IMPROPERLY INSTALLED WINDUP HOSE. AS SEEN IN THE VIDEO, THE HOSES WRAPS AROUND THE ROTARY JOINT. THIS SHOULD NOT BE THE CASE. THE HOSES SHOULD ROTATE FREELY THROUGHOUT THE GANTRY'S ROTATION. THIS MACHINE (B)(4) WAS BUILT PRIOR TO IMPROVEMENTS IN THE INSTALLATION AND REPLACEMENT PROCESSES. THE MANUFACTURING BUILD PROCEDURE (SOE) WAS UPDATED IN LATE JUNE OF 2010 TO BETTER CONTROL THE LENGTH OF THE WINDUP HOSES. THE FIELD'S PART REPLACEMENT PROCEDURE PRM-HE, WAS ALSO UPDATED WITH THE CORRECT PROCEDURE AND VERIFICATION CHECK. A SERVICE TECHNICAL BULLETIN (STB) WAS CREATED TO VERIFY AND CORRECT MACHINES IN THE FIELD. THIS STB HAD NOT YET BEEN COMPLETED AT THIS SITE AT THE TIME OF THE ADVERSE EVENT HOWEVER, THIS MACHINE IS ON THE EFFECTIVITY LIST OF THE STB. SINCE THIS ISSUE, THE DAMAGED HOSE HAS BEEN REPLACED ACCORDING TO THE CURRENT PROCEDURE AND A VERIFICATION CHECK PERFORMED. THE HOSE NO LONGER CATCHES DURING ROTATION WHICH RESOLVED THIS SITE'S ISSUE. THERE WAS NO REPORT OF INJURY OR MISTREATMENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS ANTICIPATED.

    Description of Event or Problem · 1

    A WATER HOSE CATCHES AS THE GANTRY ROTATES AND COMES OFF ALL AT ONCE CAUSING A WATER HAMMER THAT IS PICKED UP BY THE FLOW DETECTORS AND CREATING A FLOW FAULT. THE TX LINEAR ACCELERATOR CANNOT TREAT PATIENTS THAT WAY SO VARIAN ENGINEERS HAD US BYPASS ALL 4 FLOW DETECTORS UNTIL THE NEW PARTS ARRIVED. VARIAN CHANGED IT LAST NIGHT AND ALL SEEMS WELL SO FAR. HEALTH PROFESSIONAL'S IMPRESSION: THE WATER HOSE COULD HAVE CAUGHT THE GANTRY AND BROKE OPEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1