BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821328 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00339
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    July 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 (B)(4) 2012. THE PULSAR GENERATOR WAS RECEIVED IN FAIR CONDITION, WITH SEVERAL SCRATCHES ON TOP, FRONT AND SIDES. THE UNIT FUNCTIONED NORMALLY WHEN ENERGY WAS DELIVERED INTO FIXED RESISTORS. THERE WERE EXCESSIVE E2 (CUT OR COAG FOOT PEDAL SWITCH MAY BE STUCK IN THE ON POSITION) ERRORS THAT WERE A RESULT OF A UCB SOFTWARE BUG. 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 FOR THE PREVIOUS MONTH AT LEAST ONCE A CASE, THE GENERATOR WOULD DISPLAY AN ERROR MESSAGE. THEY WOULD HAVE TO STOP THE CASE TO EITHER WAIT UNTIL IT WENT AWAY OR THEY WOULD HAVE TO REBOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR GENERATOR GEI MEDTRONIC ADVANCED ENERGY LLC PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE