BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821308 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00363
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    February 23, 2012
    Report Date
    February 29, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 MONITOR SURFACE IMPERFECTIONS. WHEN POWERED UP, THE UNIT MADE A LOT OF NOISE (RESONANT VIBRATION FROM THE HEAT SINK FAN; TO BE REPAIRED BY ADDING A WASHER UNDER THE RD AMP PCBA). THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. ALL COAGULATION ENERGY APPEARED TO BE AT THE CORRECT POWER LEVELS. THE REPORTED COMPLAINT COULD NOT BE REPLICATED. 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 PROPERLY. WHEN IT WAS TURNED ON THERE WAS A LOUD NOISE. THEY HAD TO TURN UP THE COAGULATION FOR IT TO WORK, BUT IT STILL DID NOT WORK CORRECTLY. THEY WERE ABLE TO FINISH THE CASE WITH NO CUSTOMER IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE