BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821295 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00370
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    April 3, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 08/15/2010 THROUGH 08/15/2012. THE PULSAR GENERATOR WAS RECEIVED IN POOR CONDITION WITH SCRATCHES AND FADED AREAS FROM STICKERS ON THE UPPER LID SURFACE. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THE ERROR LOG SHOWED MULTIPLE DAYS WITH E3S (PATIENT RETURN ELECTRODE HAS POOR CONNECTION). THE UPGRADED RF CONTROLLER SOFTWARE 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. APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE GENERATOR STOPPED DURING SURGERY WITH A "CONNECTION FAILED" MESSAGE. THEY TURNED IT OFF AND ERROR MESSAGE WENT AWAY AND THEY WERE ABLE TO FINISH THE CASE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE