BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822140 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00278
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER FOR THE TIME PERIOD (B)(4) 2012. EVALUATION: THE PULSAR GENERATOR WAS RECEIVED IN POOR CONDITION WITH SURFACE DISCOLORATION AND SCRATCHES ON THE UPPER LID. THE CART HAD GOUGES BELOW THE SIDE VENTS, AND THE MATTE FINISH WAS SCRATCHED ON THE FRONT PANEL OVERLAY. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. IMPEDANCE IMBALANCE READINGS INDICATE THAT THE SYSTEM WAS HAVING DIFFICULTY REJECTING NOISE WHEN EVALUATING THE SPLIT-FOIL PT PAD IMPEDANCE. THE RF CONTROLLER SOFTWARE VERSION MAY NOT ALWAYS MEASURE THE IMPEDANCE OF A SPLIT FOIL PT RETURN PAD ACCURATELY WHEN ENERGY IS BEING DELIVERED. A BUG IN THAT VERSION OF SOFTWARE CAN CAUSE RF OUTPUT TO STOP WITHOUT NOTIFYING THE OPERATOR. THE CONTROLLER SOFTWARE WAS UPGRADED AND IS BETTER ABLE TO MEASURE SPLIT-FOIL PT RETURN PAD IMPEDANCE AND NOTIFIES USER WITH E3 ERROR IF THE SPLIT-FOIL IMPEDANCE RISES WHILE ENERGY IS BEING DELIVERED. APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE UNIT SHUT OFF MID-SURGERY, AND THEN WHEN TURNED BACK ON, IT WOULD NOT DISPLAY ANY NUMBERS. THERE WAS NO KNOWN PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR GENERATOR GEI MEDTRONIC ADVANCED ENERGY LLC PULSAR GENERATOR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE