BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDITRACE MULTIFUNCTION ELECTRODE

    MDR report key: 2971578 · Received March 26, 2010

    Report

    Report Number
    2971578
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Date of Event
    March 12, 2010
    Report Date
    March 26, 2010
    Manufacturer
    KENDALL / TYCO HEALTHCARE
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A CARDIOVERSION IN PACU. PRIOR TO HIS PROCEDURE, DEFIBRILLATOR PADS WERE PLACED ON THE LEFT CHEST AND RIGHT ARM POSITION, THE PT WAS SEDATED BY ANESTHESIA. DR ORDERED THE PT TO BE CARDIOVERTED AT 100 JOULES. RN TURNED THE PHILLIPS DEFIBRILLATOR TO 100 JOULES, CHARGED AND THE PT RECEIVED THE SHOCK. DR NOTICED A SMALL SPARK WHEN THE DEFIBRILLATOR WAS DISCHARGED AND STAFF SMELLED A FAINT BURNING ODOR. THE PAD WAS REMOVED AND A REDDENED AREA WAS OBSERVED ON THE PT'S LEFT LATERAL CHEST IN THE OUTLINE OF THE DEFIBRILLATOR PAD WITH A PEA SIZED RED MARK AT TOP OF PAD WHERE THE ELECTRODE IS CONNECTED ON THE LEFT LATERAL CHEST WALL. PADS WERE CHANGED FOR A DIFFERENT DEFIBRILLATOR (MEDTRONIC LIFE PACK 20), APPLIED TO THE PT'S LEFT CHEST NEAR THE XYPHOID PROCESS AND THE OTHER PAD WAS PLACED ON HIS RIGHT SCAPULA. DR ORDERED RN TO DISCHARGE ANOTHER SHOCK AT 200 JOULES AND THE PT CARDIOVERTED TO A NORMAL SINUS RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITRACE MULTIFUNCTION ELECTRODE DEFIBRILLATOR PAD MKJ KENDALL / TYCO HEALTHCARE 1210H 817804

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other MODEL M4735A, SERIAL #(B)(4)| PHILIPS HEARTSTART XL DEFIBRILLATOR