BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822138 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00285
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    November 22, 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 RECEIVED BY THE MANUFACTURER FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. THE PULSAR GENERATOR WAS RECEIVED IN FAIR CONDITION WITH MINOR SURFACE IMPERFECTIONS. THE TOP LID WAS SCRATCHED, THE FRONT PANEL OVERLAY WAS SCRATCHED. THE UNIT DELIVERY RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. ALSO FOUND C89 ON DC POWER SUPPLY PCBA HAD BEEN KNOCKED LOOSE. THE CAP WAS STILL MAKING CONTACT WITH THE PCBA BUT NEEDS TO BE REFLOWED. SINCE F5 IS THE ONLY FAULT LISTED IN ERROR LOG, IT IS ASSUMED TO BE THE REASON FOR RETURN. A F5 FAULT WILL OCCUR WHEN THE DC POWER SUPPLY BOOTS INTO AN UNCERTAIN STATE. FOR SAFETY REASONS, THE SYSTEM SHUTS OFF AND REQUIRES POWER CYCLE BEFORE IT WILL DELIVER RF ENERGY. REBOOTING CLEARS THE FAULT. 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, THE GENERATOR WAS NOT WORKING. THE LIGHTS KEPT BLINKING AND A WARNING CODE KEPT COMING UP, THEY DIDN'T REMEMBER WHAT CODE IT WAS. THERE WAS NO PT IMPACT.

    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