BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR REFURBISHED

    MDR report key: 3010791 · Received March 19, 2013

    Report

    Report Number
    1226420-2013-00075
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 22, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K073057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. RESULTS: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. CONCLUSION: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. PRODUCT EVENT: (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4) EVALUATION PROCESS: UNIT RECEIVED IN FAIR CONDITION WITH MINOR SURFACE IMPERFECTIONS. POWER CORD WAS RECEIVED. NO USER MANUAL, NOR HANDPIECE WAS RECEIVED WITH UNIT. INTERNAL VISUAL INSPECTION REVEALED NOTHING MOVING OR BROKEN IN UNIT. UNIT BOOTED INTO F8 FAULTS TWICE. ALL DC PCBA CABLES WERE RESEATED AND UNIT BOOTED SUCCESSFULLY. LVPS WAS ADJUSTED FROM 3.21 VDC TO 3.37 VDC. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. THE ERROR LOG REVEALED THAT THE UNIT WAS POWERED UP ON 2 UNIQUE DAYS WHILE IN THE FIELD. ERROR LOG CONTAINS 1 E11 (PATIENT RETURN ELECTRODE DISCONNECTED) AND 16 F8S (POWER SUPPLY VOLTAGE IS TOO LOW.) THE E11 ERROR IS CONSIDERED A 'NORMAL USE' ERROR AND IS NOT INDICATIVE OF A PROBLEM WITH THE UNIT. THE F8 FAULTS CAN BE CAUSED BY TWO SITUATIONS (A) THE BULK HIGH VOLTAGE POWER SUPPLY EXCEEDS AN UPPER OR LOWER LIMIT OR (B) THE VDD POWER TO THE U18 DSP IC IS TOO LOW. THE BULK 264 VOLT HIGH VOLTAGE OUTPUT WAS FOUND TO MEASURE CORRECTLY AT 359 VDC. THE DC POWER SUPPLY PCBA U18 VDD 3.3 VOLT WAS CHECKED AND MEASURED ONLY 3.19 VDC. ADJUSTING THE LVPS FROM 3.21 VDC TO 3.37 VDC RAISED THE LVPS VDD TO 3.30 VDC. THIS SHOULD ELIMINATE FURTHER F8 FAULTS FROM OCCURRING DUE TO LOW VDD VOLTAGE. UNIT WAS SUCCESSFULLY BOOTED 60 TIMES TO VERIFY THAT IT NO LONGER BOOTED INTO AN F8 FAULT CONDITION. ROOT CAUSE: THE VOLTAGE AT THE 'VDDA' INPUT OF THE DSP (3.30 +/-0.01V, GENERATOR ON-BOARD, THAT POWERS THE DSP'S ANALOG CIRCUITRY) IS TYPICALLY LARGER THAN THE VOLTAGE AT THE 'VDD' INPUT OF THE DSP (NOMINAL 3.3V THAT POWERS THE DSP'S DIGITAL CIRCUITRY.) THE NOMINAL 3.3 V FOR THE 'VDD' INPUT IS GENERATED RELATIVELY FAR AWAY, AT THE LOW VOLTAGE POWER SUPPLY (LVPS), AND EXPERIENCES A VOLTAGE DROP BY THE TIME IT REACHES THE DSP. A DIFFERENCE BETWEEN THESE TWO VOLTAGES CAN CAUSE AN OSCILLATION TO THE 'VDDA' VOLTAGE, WHICH LEADS TO INCORRECT ANALOG VOLTAGE READINGS AND, HENCE, FALSE F8 FAULTS. ADJUSTING THE LVPS ELIMINATES THIS ISSUE. (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

    DURING A SURGICAL PROCEDURE THE GENERATOR FLASHED AN ERROR CODE INDICATING LOW VOLTAGE AND ENERGY DELIVERY CEASED. REBOOTING THE GENERATOR DID NOT CLEAR THE ERROR SO ANOTHER GENRATOR WAS UTILIZED TO COMPLETE THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE THE GENERATOR FLASHED AN ERROR CODE INDICATING LOW VOLTAGE AND ENERGY DELIVERY CEASED. REBOOTING THE GENERATOR DID NOT CLEAR THE ERROR SO ANOTHER GENRATOR WAS UTILIZED TO COMPLETE THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114693 GENERATOR PULSAR REFURBISHED GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-100RF

    Patients

    Seq Age Sex Outcome Treatment
    1