BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821340 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00355
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 27, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FIELD BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER FOR THE TIME PERIOD (B)(4) 2010 THROUGH (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. IN THE ERROR LOG, THERE WAS A LONG STRING OF ERROR CODES SUGGESTING THAT THE UNIT WAS BEING USED UNSUCCESSFULLY WITH A SPLIT FOIL PATIENT RETURN PAD. THE RF CONTROLLER SOFTWARE UPGRADE WILL REDUCE THE NUMBER OF FALSE ERRORS THAT APPEAR DUE TO NOISE I THE IMPEDANCE MEASUREMENT SYSTEM. THE UNIT WAS REPAIRED. 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 WAS NOT WORKING PROPERLY, THERE WERE INCORRECT OUTPUTS. NO PATIENTS WERE AFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE