BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEAK PULSAR II GENERATOR

    MDR report key: 5056009 · Received September 4, 2015

    Report

    Report Number
    1226420-2015-00147
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 7, 2015
    Report Date
    October 5, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT (B)(4). EVALUATION PROCESS: *PERFORMED VISUAL INSPECTION ON UNIT PER (B)(4). - UNIT HAS BARE METAL ON BOTH BOTTOM SIDES OF ENCLOSURE. *PERFORMED BASELINE FUNCTIONAL TESTING PER (B)(4). - NO PERFORMANCE ISSUES FOUND. UNIT DELIVERED CORRECT RF ENERGY IN BOTH CUT <(><<)>(><(>&<)><(><<)>)> COAG. ROOT CAUSE: THE RESISTIVE LOADS USED INSIDE COMMERCIAL OFF-THE-SHELF ANALYZERS ARE LOCATED IN EARTHED METAL ENCLOSURES. THE ENERGY BEING DELIVERED BY THE PULSAR II IS SHUNTED OFF TO THE EARTHED ENCLOSURE IN THE FORM OF RF LEAKAGE CURRENT¿WHICH CAN CONFUSE THE POWER READING OF THE ANALYZER BECAUSE IT TRIES TO MONITOR CURRENT AND VOLTAGE. OUR MEASUREMENT SYSTEM PLACES THE RATED LOAD ON A WOODEN TABLE WHERE IT IS ISOLATED FROM EARTHED METAL. WE USE FLUE TRUE RMS METERS THAT MEASURE ACTUAL HEAT PRODUCED BY THE WAVEFORM. OUR SET-UP IS NOT CONFUSED BY THE COUPLED RF LEAKAGE CURRENT AND GENERATES ACCURATE READINGS. (AS PER (B)(4) ¿ SR. ELECTRICAL ENGINEER). BARE METAL ON ENCLOSURE IS DUE TO ROUGH HANDLING OUT IN THE FIELD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BIOMED PERFORMED PREVENTATIVE MAINTENANCE TESTING USING A DNI 454 ESU ANALYZER AND A TNA DEVICE AND FOUND THAT THE OUTPUT ON ALL SETTINGS BELOW COAG 5 WERE HIGHER THAN THE ALLOTTED TOLERANCE.THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    BIOMED PERFORMED PREVENTATIVE MAINTENANCE TESTING USING A DNI 454 ESU ANALYZER AND A TNA DEVICE AND FOUND THAT THE OUTPUT ON ALL SETTINGS BELOW COAG 5 WERE HIGHER THAN THE ALLOTTED TOLERANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588187 PEAK PULSAR II GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1