BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 1843660 · Received September 21, 2010

    Report

    Report Number
    2916710-2010-00108
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K061140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILED SWIVEL JOINTS WERE INVESTIGATED BY MANUFACTURING AND VENDOR. THIS INVESTIGATION WAS PROMPTED BY AN INCREASED USAGE OF SWIVEL JOINTS IN THE INSTALLATION & WARRANT REPORTS FOR A SPECIFIC RANGE OF MACHINES. IT WAS DETERMINED THAT THE GANTRY SWIVEL JOINT FAILURES ARE THE RESULT OF HOSES THAT CONNECT THE JOINTS TO THE STAND BEING TOO SHORT. POSSIBLE SECONDARY CONTRIBUTORS ARE THE ROUTING OF THE WINDUP WATER HOSES AND THE ASSEMBLY TECHNIQUE OF THE SWIVEL JOINT VENDOR. A SAMPLE OF MACHINES WAS TESTED FOR WATER HOSE LENGTH AND IT WAS DETERMINED THAT 70 TO 80 % OF MACHINES WITHIN THE SPECIFIED RANGE WILL LIKELY HAVE WATER HOSES THAT ARE TOO SHORT THAT WILL RESULT IN SWIVEL JOINT FAILURES. FAILURE OF THE SWIVEL JOINTS CAN RESULT IN WATER AND ELECTRICAL DAMAGE TO VARIOUS EQUIPMENT THROUGH OUT THE MACHINE DEPENDING ON THE ANGLE OF THE GANTRY AND THE SEVERITY OF THE LEAK. WHEN WATER IS IN CONTACT WITH HIGH VOLTAGE SOURCES: WATER THAT CONTACTS HIGH VOLTAGE CAN BECOME CONDUCTIVE. IF THE WATER DOES NOT COME IN CONTRACT WITH A GROUNDED LOCATION THAT TRIPS SOME TYPE OF PROTECTIVE DEVICE IT CAN STAY AT A HIGH VOLTAGE. A PERSON THAT COMES IN CONTACT WITH THE WATER CAN BE INJURED IF THE CURRENT IS HIGH ENOUGH. HOWEVER, VARIAN HAS NOT REC'D ANY REPORTS INVOLVING ANY INJURY DUE TO THIS TYPE EVENT. 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 F/U REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    IN (B)(6) 2009, VARIAN CSS REC'D REPORTS FROM A CUSTOMER WHO NOTICED WATER LEAKS ORIGINATING FROM THEIR CLINAC. FAILURE OF SWIVEL JOINT WAS IDENTIFIED AS THE ROOT CAUSE OF THE WATER LEAK BY LOCAL SERVICE REP; REMEDY/FIX WAS REPLACEMENT OF OLD SWIVEL JOINT WITH NEW SWIVEL JOINT. SUBSEQUENT TO THIS COMPLAINT, SEVERAL OTHER CUSTOMERS REPORTED SIMILAR WATER LEAKS FROM THE SWIVEL JOINTS. THERE HAVE BEEN NO REPORTS OF SERIOUS INJURY TO A PT OR USER AND NO PT INFORMATION HAS BEEN PROVIDED IN THESE CASES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1