BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822139 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00282
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    MEDTORNIC 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. EVALUATION: THE PULSAR GENERATOR WAS RECEIVED IN FAIR CONDITION WITH LIGHT SCRATCHES. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THE COMMUNICATION CABLE BETWEEN THE UCB AND RF CONTROLLER HAD THE COMMUNICATION WIRES TWISTED TO REDUCE SUSCEPTIBILITY TO NOISE. THE NUMBER OF TWISTS PER INCH IS WITHIN SPEC BUT WILL BE TWISTED FURTHER TO REACH THE HIGHER LIMIT OF SPECIFICATION. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE MULTIPLE F6 ERRORS. THEY REBOOTED AND IT WORKED FINE AND THEN AN F6 APPEARED AGAIN. THERE WAS NO PT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE