BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822242 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00442
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 16, 2010
    Report Date
    September 16, 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 REC'D BY THE MFR FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. THE PULSAR SYSTEM WAS REC'D IN POOR CONDITION WITH A WIPEDOWN PATCH NOTICEABLE ON THE UPPER CASE SURFACE. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THE SYSTEM EXHIBITED 2 F6 FAULTS IN 9 DAYS OF USE. THE COMMUNICATION WIRES IN THE UCB TO RF CONTROLLER CABLE WERE TWISTED AT A RATE OF 2-3 TWISTS PER INCH TO TRY AND REDUCE THE F6 FAULTS DUE TO RF NOISE. THE CABLE MET SPECIFICATIONS, BUT THE WIRES WILL BE TWISTED TIGHTER IN AN EFFORT TO REDUCE THE INCIDENCE OF F6 COMMUNICATION FAULTS. APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. THE UNIT PASSED ALL FINAL TESTING AND WAS RECERTIFIED FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN F6 ERROR (RF MODULE COMMUNICATION WITH THE CONTROLLER PROCESSOR HAS FAILED) TWICE. ALTHOUGH THERE WAS A PT ON THE TABLE (CASE WAS A LUMPECTOMY), THERE WAS NO PT IMPACT DUE TO THE GENERATOR. THEY SWITCHED IT OFF AND MOVED IT OUT OF THE ROOM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE