BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821476 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00297
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    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) 2010 THROUGH (B)(4) 2012. THE PULSAR GENERATOR WAS RECEIVED IN POOR CONDITION WITH SCRATCHES AND SURFACE IMPERFECTIONS ON THE UPPER LID. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THE COMPONENTS USED TO DETECT PT PAD IMBALANCE ARE OPERATING CORRECTLY. THE REPORTED PROBLEM WAS "RED ERROR MESSAGES". THE REPORTED PROBLEM WAS NOT CONFIRMED; THERE WERE NO UNUSUAL ERROR MESSAGES IN THE LAST 5 MONTHS OF USE. APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. IT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED ERROR CODES APPEARED DURING CASES AND IN TRAINING. THEY WERE RED ERROR MESSAGES. 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 GENRATOR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE