BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1500T14 RF GENERATOR

    MDR report key: 2063128 · Received March 22, 2011

    Report

    Report Number
    2030404-2011-00080
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL EVALUATION OF THE RETURNED GENERATOR AND REMOTE CONTROL CONFIRMED A FAILURE OF THE 'START/STOP" BUTTON TO INITIATE OR STOP ABLATION WHEN PRESSED. WE ARE IN THE PROCESS OF FURTHER EVALUATION TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN OUR INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED AT THE END OF AN ABLATION PROCEDURE, THE RN MISTAKENLY HIT THE REMOTE CONTROL 'START/STOP" BUTTON TWICE IN RAPID SUCCESSION WHICH CAUSED THE SYSTEM TO FREEZE. THE USER WAS UNABLE TO STOP RF USING THE REMOTE CONTROL OR THE 'START/STOP" BUTTON ON THE T14 GENERATOR ITSELF. THE RF DELIVERY STOPPED ON ITS OWN ABOUT 20 SECONDS LATER. THERE WERE NO PATIENT COMPLICATIONS. FOLLOWING THE CASE, A NEW EXTENDER MODULE WAS INSTALLED TO AVOID USE OF THE REMOTE CONTROL BUT IT WAS NOTED THAT THE CONTROLS ON THE REMOTE AND GENERATOR NO LONGER FUNCTIONED PROPERLY. THE USER COULD NOT ADJUST TIME, POWER, IMPEDANCE, TEMPERATURE, TD, OR PID AND THE 'SET UP TEST" AND "CLEAR" BUTTONS WOULD NOT FUNCTION. ADJUSTING ONE FUNCTION USING THE ARROW KEYS, WOULD ADJUST ANOTHER PARAMETER INSTEAD. ADDITIONALLY, WHEN TRYING TO ADJUST REMOVE FUNCTIONS, THE COOL POINT PUMP STARTED TWICE WITHOUT ABLATION BEING INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1500T14 RF GENERATOR NONE OAD ST. JUDE MEDICAL, IRVINE 100029905 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 REMOTE CONTROL: MODEL #89018, (B)(4)