BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822131 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00291
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    November 10, 2010
    Report Date
    November 29, 2010
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. THE PULSAR GENERATOR WAS RECEIVED IN FAIR CONDITION WITH MINOR SURFACE IMPERFECTIONS. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THE UNIT EXHIBITED TWO F6 (COMMUNICATION WITH THE CONTROLLER PROCESSOR FAILED) FAULTS ON THE LAST DAY OF USE. THE UNIT WAS REPAIRED AND APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. IT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE. END OF REPORT.

    Description of Event or Problem · 1

    DURING A MASTECTOMY PROCEDURE, THE GENERATOR CUT OFF AND GAVE AN ALARM. THE DOCTOR WAS PROMPTED TO TURN THE MACHINE OFF, UNHOOK THE HANDPIECE AND RESTART THE MACHINE; THE CASE RESUMED. THERE WAS NO PATIENT 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