BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II GENERATOR

    MDR report key: 2867920 · Received December 11, 2012

    Report

    Report Number
    1226420-2012-00096
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 7, 2012
    Report Date
    January 25, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT# (B)(4). EVALUATION PROCESS: UNIT RECEIVED IN GOOD CONDITION AND INTERNAL VISUAL INSPECTION REVEALED NO LOOSE OR BROKEN COMPONENTS. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. TO ESTABLISH THAT THE UNIT DELIVERED ENERGY CORRECTLY WITHOUT LOCKING UP, THE ACTIVE BURN-IN PORTION OF THE TEST PROCEDURE TP-0048 WAS PERFORMED. THE UNIT WAS POWERED UP AND IN THE IDE CONDITION FOR 72 HOURS WITH NO LOAD, THE UNIT PASSED WITH NO ISSUES. ERROR LOG: 9 E3'S (PATIENT RETURN ELECTRODE HAS POOR CONNECTION) AND E3 IS A NORMAL USE ERROR. ROOT CAUSE: COULD NOT DUPLICATE THE STATED COMPLAINT. UNIT PUT THROUGH ACTIVE BURN-IN TESTING WITHOUT ISSUE. THERE ARE 9 E3'S IN THE ERROR LOG AND THE UNIT WAS ABLE TO EXHIBIT E3 ERRORS WITHOUT FREEZING UP. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD, RESULTS AND CONCLUSION: GENERATOR RETURNED AND EVALUATION IS UNDERWAY. PRODUCT EVENT # (B)(6).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    GENERATOR SCREEN FROZE MID-PROCEDURE AND SETTINGS CANNOT BE ADJUSTED UP OR DOWN. SWITCHED TO ELECTROCAUTERY TO COMPLETE CASE.

    Description of Event or Problem · 1

    GENERATOR SCREEN FROZE MID-PROCEDURE AND SETTINGS CANNOT BE ADJUSTED UP OR DOWN. SWITCHED TO ELECTROCAUTERY TO COMPLETE CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1