BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822259 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00257
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 2, 2010
    Report Date
    September 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 REC'D BY THE MFR FOR THE TIME PERIOD 08/15/2010 THROUGH 08/15/2012. EVAL: THE PULSAR GENERATOR WAS REC'D; THERE WAS NO POWER CORD, USER MANUAL OR HAND PIECE. THE UNIT WAS IN FAIR CONDITION WITH MINOR SURFACE IMPERFECTIONS. IMPEDANCE IMBALANCE READINGS INDICATE THAT THE SYSTEM WAS HAVING DIFFICULTY REJECTING NOISE WHEN EVALUATING THE SPLIT-FOIL PT PD 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. THE SOFTWARE WAS UPGRADED FOR THE RF CONTROLLER AND HAS FOLLOWING CHANGES: NO LONGER FLAGS E3 ERROR IS IMPEDANCE DROPS BELOW 15 OHM AND EVALUATES LAST 500 MS OF IMPEDANCE READINGS TO CALCULATE THE IMPEDANCE, RATHER THAN THE LAST 50 MS. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TOTAL HIP ARTHROSCOPY, THE GENERATOR ALARMED TWICE, ERROR SAID "POWER SUPPLY DOES NOT HAVE ENOUGH VOLTAGE" THEN TOWARDS THE END OF THE CASE, THE COAG WOULD NOT WORK. BECAUSE IT WOULD NOT COAGULATE, THE PT BLED UNTIL WE PLUGGED IN A BOVIE. THE PT WAS OBESE. THE SALIENT (AQUAMANTYS) WAS UNDERNEATH THE GENERATOR.

    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