BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822227 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00259
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 (B)(4) 2010 THROUGH (B)(4) 2012. EVAL: THE PULSAR GENERATOR WAS REC'D IMPROPERLY PACKED FOR SHIPMENT. REC'D POWER CORD BUT NO USER MANUAL OR HAND PIECE. THE UNIT WAS IN POOR CONDITION WITH SURFACE IMPERFECTIONS AND SPLOTCHES. THE E3 ERRORS ARE FALSE-POSITIVE "SPLIT FOIL PAD LOSING RELIABLE CONNECTION" ERRORS. UPGRADED RF CONTROLLER SOFTWARE WAS PERFORMED WHICH HAS THE 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 MADE CONTINUAL BEEPING SOUNDS AND THE SCREEN WENT BLANK. IT APPEARED THE LCD SCREEN HUNG IN THE TESTING MODE. THERE WERE VERTICAL LINES ACROSS THE SCREEN. THE CASE RESUMED WITH THE BOVIE. THE BOVIE HAD BEEN UNDERNEATH AT THE TIME OF THE ISSUE, BUT WAS NOT PLUGGED IN.

    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