BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822220 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00262
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 MFR FOR THE TIME PERIOD 08/15/2010 THROUGH 08/15/2012. EVAL: THE PULSAR GENERATOR WAS RETURNED ALONG WITH THE POWER CORD AND USER'S MANUAL; NO HANDPIECES WERE RETURNED. INITIALLY, THE UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. HOWEVER, AFTER A FEW MINUTES, IT STARTED GENERATING F8 ERRORS WHEN ENERGY WAS KEYED. ON A LATER DATE, THE F8 ERRORS COULD NOT BE REPLICATED. WHEN USED WITH THE TEST FIXTURE, THE DC POWER SUPPLY PCBA WOULD POWER UP CORRECTLY BUT COULD BE FORCED INTO AN OVERVOLTAGE CONDITION BY WARMING THE FEEDBACK COMPONENTS WITH A HEAT GUN TO SIMULATE THE UNIT BEING USED FOR AN EXTENDED PERIOD OF TIME. HIGH VOLTAGE ON THE DC POWER SUPPLY PCBA WAS NEAR THE HIGHEST ALLOWABLE VALUE AND COULD BE MADE TO GO INTO AN OVERVOLTAGE CONDITION (GENERATING FB FAULTS). DC POWER SUPPLY PCBA WAS ADJUSTED TO MOVE THE HIGH VOLTAGE AWAY FROM CRITICAL (F8 FAULT) VALUES. APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TOTAL HIP PROCEDURE, THE SETTINGS WERE AT 6 FOR CUT AND 6 FOR COAG. THE ERROR READING OF LOW VOLTAGE KEPT APPEARING AND THE BLADE STOPPED WORKING. THEY TRIED SEVERAL TIMES TO REBOOT, BUT IT KEPT APPEARING.

    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