BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY TX (NOVALIS TX)

    MDR report key: 1991477 · Received January 28, 2011

    Report

    Report Number
    2916710-2010-00169
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K070094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A MALFUNCTION OF THE DEVICE MAY HAVE OCCURRED. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS MALFUNCTION AND RESULTING SMALL FLAME, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    WHILE PERFORMING A ROUTINE MONTHLY CHECK, THE MACHINE WAS SET TO STAND-BY, THEN POWERED DOWN VIA EMERGENCY STOP. UPON POWERING UP, THERE WAS A BUZZ AND A POP RESULTING IN INABILITY TO BRING UP THE CONSOLE COMPUTER. WHILE TROUBLE-SHOOTING, A VARIAN FIELD REPRESENTATIVE REMOVED THE POWER UNIT; TESTING THE INCOMING 115VDC TO THE PS1 SHOWED NO POWER. THE FIELD REPRESENTATIVE FOUND THAT THE FUSE WAS OPEN (BLOWN) AND HAD A BURN RING ON IT. PRIOR TO REPLACING THE FUSE, THE FIELD REP ISOLATED THE PS1 OUTPUT SO THAT ONLY INCOMING VOLTAGE WAS CONNECTED. THE FUSE WAS REPLACED AND POWER WAS RESTORED TO THE POWER SUPPLY. UPON POWERING UP, THERE WAS A BUZZ SOUND FOLLOWED BY A SPARK AND SMALL FLAME ABOUT THE SIZE OF A CANDLE; THE FUSE DID NOT BLOW UPON REINITIATING POWER. IMMEDIATELY, THE POWER WAS CUT OFF AND THE SMALL FLAME EXTINGUISHED. THERE WAS NO HARM OR SERIOUS INJURY REPORTED ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY TX (NOVALIS TX) CHARGED-PARTICLE RADIATION THERAPY SYS IYE VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS H29

    Patients

    Seq Age Sex Outcome Treatment
    1