BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822224 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00260
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 17, 2010
    Report Date
    September 17, 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) 2012. EVAL: THE PULSAR GENERATOR WAS RETURNED, THERE WAS NO POWER CORD, USER MANUAL OR HANDPIECES. THE UNIT WAS IN FAIR CONDITION WITH MINOR SURFACE IMPERFECTIONS. THE ERROR LOG SUMMARY REVEALED AN F5 FAULT (RF MODULE MONITOR HAS DETECTED A RF MODULE FAILURE). THE F5 FAULT WILL OCCUR WHEN THE DC POWER SUPPLY BOOTS INTO AND UNCERTAIN STATE. FOR SAFETY REASONS, THE SYSTEM MUST BE POWER CYCLED BEFORE IT CAN DELIVER RF ENERGY. THIS UNIT HAD APPLICABLE SOFTWARE AND HARDWARE UPGRADES AND WAS RECERTIFIED FOR USE. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A CARDIAC CATH CASE, THE GENERATOR BEGAN TO MAKE BEEPING SOUNDS "LIKE IT WAS A VIDEO GAME" AND THEN THE ORANGE SCREEN CAME UP. THE GENERATOR HAD TO BE RESET AND THE CASE CONTINUED. THERE WERE NO PT AFFECTED.

    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