BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821430 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00319
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    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 REC'D BY THE MFR FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. THE PULSAR GENERATOR WAS REC'D IN FAIR CONDITION WITH MINOR SCRATCHES ON THE SURFACE. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THE UNIT EXHIBITED 5 F6 FAULTS IN THE LAST 9 DAYS OF USE. PULSAR UNITS ARE SUBJECT TO F6 FAULT CODES FROM TIME TO TIME. ANECDOTAL EVIDENCE SUGGESTS THAT THE LOCATION OF OTHER EQUIPMENT IN THE SURGICAL FIELD CAN AFFECT A GENERATOR'S ABILITY TO COMMUNICATE INTERNALLY W/O F6 FAULTS. THE RF CONTROLLER TO UCB WIRE HARNESS WAS REPLACED TO ADDRESS THE COMMUNICATION ISSUE. THE UNIT WAS REPAIRED AND 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 THERE WERE ERROR CODES F6 (RF MODULE COMMUNICATION WITH THE CONTROLLER PROCESSOR HAS FAILED) WITH A NEW GENERATOR. THERE WAS NO PT INJURY.

    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