BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822134 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00288
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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) 2010 THROUGH (B)(4) 2012. THE PULSAR GENERATOR WAS RECEIVED IN FAIR CONDITION WITH MINOR SURFACE IMPERFECTIONS AND CART GOUGES BELOW THE FRONT SIDE VENTS. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THERE WAS BROKEN AND DAMAGED HARDWARE IN THE UNIT WHICH WAS REPLACED. REPAIRS WERE PERFORMED AND THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE. THE F6 FAULTS INDICATE A TEMPORARY LOSS OF COMMUNICATION BETWEEN THE UCB AND RF CONTROLLER. REBOOTING CLEARED THE FAULT EACH TIME. APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. THE UNIT WAS REPAIRED AND PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE THREE F6 ERROR MESSAGES IN THE SAME CASE AFTER A REBOOT THE FIRST AND SECOND TIME. THEY COULD NO LONGER USE THE GENERATOR. 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