BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERATOR PULSAR2

    MDR report key: 2981261 · Received February 27, 2013

    Report

    Report Number
    1226420-2013-00042
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 30, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. RESULTS: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. CONCLUSION: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. PRODUCT EVENT: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION PROCESS: UNIT RECEIVED IN GOOD CONDITION WITH VERY MINOR SURFACE IMPERFECTIONS. POWER CORD WAS RECEIVED. NO HAND PIECES NOR USER MANUAL WERE RECEIVED. INTERNAL VISUAL INSPECTION REVEALED NO LOOSE OR BROKEN COMPONENTS. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. UNIT WAS POWERED UP ON AT LEAST 2 DAYS IN THE FIELD. ERROR LOG CONTAINS 3 E3S (PATIENT RETURN ELECTRODE HAS POOR CONNECTION). THE E3 ERRORS ARE CONSIDERED "NORMAL USE" ERRORS AND ARE NOT INDICATIVE OF PROBLEMS WITH THE UNIT. ROOT CAUSE: THE UNIT FUNCTIONED AS DESIGNED IN THE SERVICE DEPARTMENT. (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 BIOMED TESTING (NOT IN ACCORDANCE WITH IEC60601) BIOMED STATED RETURN PAD WAS HOT TO THE TOUCH (NO BURN) WHEN TESTING OUTPUT OF GENERATOR. TESTING WAS CONDUCTED AGAIN AND BIOMED AND ACCOUNT MANAGER RECEIVED 1ST DEGREE BURNS WHEN TESTING OUTPUT OF THE GENERATOR. GENERATOR TESTED FOR OUTPUT IN BIOMED LAB. GENERATOR PLUGGED INTO GFI OUTLET AND WHEN SETTINGS SET ON COAG 9, CUT 10, AND COAG 7 CUT 7, BREAKER FLIPS AND GENERATOR TO SHUTS OFF (GENERATOR AND GFI WERE RESET/REBOOTED BETWEEN EACH OF THE ABOVE CIRCUMSTANCES) GENERATOR PUT INTO SERVICE IN THE HOSPITAL AND CAUSED INTERFERENCE (SHUT DOWN) OF ONE OF THE EP VISUAL BOOM MONITORS DURING ACTIVATION OF "CUT" MODE OF PLASMABLADE DEVICE. PROCEDURE CONTINUED WITH MONITOR OFF.

    Description of Event or Problem · 1

    DURING BIOMED TESTING (NOT IN ACCORDANCE WITH IEC60601) BIOMED STATED RETURN PAD WAS HOT TO THE TOUCH (NO BURN) WHEN TESTING OUTPUT OF GENERATOR. TESTING WAS CONDUCTED AGAIN AND BIOMED AND ACCOUNT MANAGER RECEIVED 1ST DEGREE BURNS WHEN TESTING OUTPUT OF THE GENERATOR. GENERATOR TESTED FOR OUTPUT IN BIOMED LAB. GENERATOR PLUGGED INTO GFI OUTLET AND WHEN SETTINGS SET ON COAG 9, CUT 10, AND COAG 7 CUT 7, BREAKER FLIPS AND GENERATOR TO SHUTS OFF (GENERATOR AND GFI WERE RESET/REBOOTED BETWEEN EACH OF THE ABOVE CIRCUMSTANCES) GENERATOR PUT INTO SERVICE IN THE HOSPITAL AND CAUSED INTERFERENCE (SHUT DOWN) OF ONE OF THE EP VISUAL BOOM MONITORS DURING ACTIVATION OF "CUT" MODE OF PLASMABLADE DEVICE. PROCEDURE CONTINUED WITH MONITOR OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83724 GENERATOR PULSAR2 GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1