BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822264 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00256
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    August 30, 2010
    Report Date
    August 30, 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 MFR FOR THE TIME PERIOD (B)(4) 2012. EVAL; THE UNIT WAS RECEIVED ALONG WITH THE POWER CORD; THERE WAS NO USER MANUAL OR HANDPIECE. THE ERROR LOG REVEALED A F5 FAULT (RF MODULE MONITOR HAS DETECTED A RF MODULE FAILURE). AN F5 FAULT WILL OCCUR WHEN THE DC POWER SUPPLY BOOTS INTO AN UNCERTAIN STATE. FOR SAFETY REASONS, THE SYSTEM MUST BE POWER-CYCLED BEFORE IT CAN DELIVER RF ENERGY. THIS UNIT WAS REPAIRED AND HAD APPLICABLE SOFTWARE/HARDWARE UPGRADES AND WAS RECERTIFIED FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ERROR MESSAGE STATED "CONDUCTIVITY TOO LOW".

    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