BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822164 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00276
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    October 19, 2010
    Manufacturer
    MEDTORNIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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)(6) 2012. EVALUATION : THE PULSAR GENERATOR WAS RECEIVED FAIR CONDITION. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. THE RF CONTROLLER SOFTWARE VERSION MAY NOT ALWAYS MEASURE IMPEDANCE OF A SPLIT-FOIL PT RETURN PAD ACCURATELY WHILE ENERGY IS BEING DELIVERED. THE RF CONTROLLER SOFTWARE WAS UPGRADED AND HAS THE FOLLOWING CHANGES: IT NO LONGER FLAGS AN E3 ERROR IF IMPEDANCE DROPS BELOW 15-OHM AND EVALUATES LAST 500MS OF IMPEDANCE READINGS TO CALCULATE IMPEDANCE, RATHER THAN JUST THE LAST 50MS. 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

    THERE WAS A RETURN ELECTRODE ERROR REPEATEDLY. THE BLADES WERE SWITCHED AND THE SAME THING HAPPENED. THE GREEN GROUNDING GRAPH WAS ALL GREEN, INDICATING A GOOD GROUND. THERE WAS NO PT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE