BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR 2 GENERATOR

    MDR report key: 4247523 · Received November 13, 2014

    Report

    Report Number
    1226420-2014-00111
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    October 17, 2014
    Report Date
    December 3, 2014
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT # (B)(4). EVALUATION, (METHOD), (RESULT), CONCLUSION): GENERATOR RETURNED FOR ANALYSIS AND ANALYSIS RESULTS PENDING. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #700755541 COMPLAINT NOT CONFIRMED LHR/DHR REVIEW: NO ASSOCIATED MANUFACTURING OR SERVICING ISSUES. EVALUATION PROCESS: PERFORMED VISUAL INSPECTION ON UNIT PER TCL-514-900008. -UNIT HAS GOUGES AND SCRATCHES DOWN TO THE EXPOSED METAL. PERFORMED BASELINE FUNCTIONAL TESTING PER TCL-514-900008. -NO ISSUES ROUND. DELIVERED RF ENERGY PROPERLY IN ALL MODES. ROOT CAUSE: COULD NOT CONFIRM REPORT OF LOW POWER. ALL MODES OF POWER WERE DELIVERED WITHIN SPECIFICATION. THE COMPLAINT NOTED THAT A TNA HANDPIECE WAS USED TO PERFORM THE TEST. A TNA HANDPIECE HAS A POWER SETTING OF 40W FOR CUT 8 AND A POWER SETTING OF 50W FOR COAG 5. THIS SUGGESTS THAT THE VALUES MEASURED BY THE BIOMED OF 39.7W FOR CUT 8 (WITHIN 1% OF TARGET) AND 48.4W FOR COAG 5 (WITHIN 4% OF TARGET) WERE ACTUALLY WITHIN SPECIFICATION. GOUGES AND SCRATCHES ON ENCLOSURE DUE TO ROUGH HANDLING IN THE FIELD.

    Description of Event or Problem · 1

    DURING A CHECK OF THE SYSTEM IN BIOMED THE UNIT FAILED THE ROUTINE TESTING. THERE WAS HIGH OUTPUT ON SETTING COAG 5.THE UNIT WAS TESTED THREE TIMES, ONCE WITH THE PLASMABLADE DEVICE AND TWICE WITHOUT. THE UNIT WAS PLUGGED INTO A POWER STRIP THE FIRST TWO TIMES AND A WALL OUTLET THE LAST TIME. THERE WAS NO CHANGE IN TEST RESULTS.

    Description of Event or Problem · 1

    DURING A CHECK OF THE SYSTEM IN BIOMED THE UNIT FAILED THE ROUTINE TESTING. THERE WAS HIGH OUTPUT ON SETTING COAG 5.THE UNIT WAS TESTED THREE TIMES, ONCE WITH THE PLASMABLADE DEVICE AND TWICE WITHOUT. THE UNIT WAS PLUGGED INTO A POWER STRIP THE FIRST TWO TIMES AND A WALL OUTLET THE LAST TIME. THERE WAS NO CHANGE IN TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731882 PULSAR 2 GENERATOR GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1