BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822183 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00266
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    October 5, 2010
    Report Date
    October 5, 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. EVAL: THE PULSAR GENERATOR WAS RECEIVED IN POOR CONDITION WITH UPPER LID SURFACE SCRATCHES. A POWER CORD WAS RECEIVED BUT NEITHER A USER MANUAL NOR ANY HAND PIECES WERE RECEIVED. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. THE LOGGED F6 FAULT ALARM OCCURRED ON THE LAST FIELD DAY OF USE AND IS THE REASON FOR RETURN. THE F6 FAULT INDICATES A TEMPORARY LOSS OF COMMUNICATION BETWEEN THE UCB AND THE RF CONTROLLER. FOR SAFETY REASONS, THE UNIT MUST BE REBOOTED BEFORE IT WILL AGAIN DELIVER RF ENERGY. THE F6 FAULT OCCURRED ONCE. APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. THE UNIT USED FINAL TESTING AND WAS RECERTIFIED FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE F6 FAULTS THAT APPEARED.

    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