BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821338 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00356
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    January 3, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 POOR CONDITION, WITH STAINS, WORN RUBBER FEET AND OTHER IMPERFECTIONS. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THE UNIT GAVE E3 ERRORS DURING TP-005 TESTING. THE C15 WAS REPLACED ON THE RF CONTROLLER PCBA AND THE UNIT NO LONGER DISPLAYED E3 DURING THE IMBALANCE TESTING. 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, INTERMITTENT DURING A CASE. THEY SWITCHED TO A FINGER CONTROL AND WERE ABLE TO CONTINUE WITH 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE