BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821436 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00310
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    March 10, 2011
    Report Date
    March 10, 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 SURFACE IMPERFECTIONS. THE UNIT WAS POWERED ON AND DID NOT DELIVER CUT ENERGY. THE ULTRAVOLT HIGH VOLTAGE POWER SUPPLY WAS NOT PROVIDING POWER OUTPUT. THE REGULAR CUT AND COAG DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THE FOOTSWITCH FUNCTIONED PROPERLY WITH THE GENERATOR CONNECTED. BOTH INTERNAL LEDS OF THE OPTOCOUPLER FAILED IN THE OPEN CONDITION, WHICH PREVENTED THE ULTRAVOLT POWER SUPPLY OUTPUT FROM BEING ENABLED RESULTING IN FAILURE TO DELIVER PEAK CUT ENERGY. 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 DURING A T AND A PROCEDURE, THE MACHINE BEEPED "ERROR CODE GROUNDING PAD" AND DID IT INTERMITTENTLY SEVERAL TIMES. THEY TRIED TURNING THE UNIT OFF AND OUT AND CHANGED OUT THE GROUNDING PAD. THE ERROR CODE WAS THOUGH TO BE ABOUT THE GROUNDING PAD, BUT THE REP WAS NOT SURE. THE CASE RESUMED BUT THEY HAD TO USE SUCTION CAUTERY BECAUSE IT KEPT GOING ON AND OFF WITH THE ALARM. THE PT HAD ONE SIDE DONE WITH THE PEAK DEVICE AND THE REST WAS DONE WITH ELECTRIC CAUTERY.

    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