BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADENCE ZOLL PRECONNECT

    MDR report key: 3061808 · Received March 29, 2013

    Report

    Report Number
    1219103-2013-00007
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 7, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION , THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH DEFIBRILLATION ELECTRODES. THE CUSTOMER REPORTS THAT DURING A CODE BLUE (CARDIAC RESUSCITATION) PROCEDURE, ON AN (B)(6) MALE WITH A VERY HAIRY CHEST, THE DEFIBRILLATION ELECTRODES SPARKED AND ARCED. THEY DID NOT DEFIBRILLATE. A 2ND PAIR OF COVIDIEN CADENCE ELECTRODES WERE PLACED AND DEFIBRILLATED THE PT WITHOUT ANY TROUBLE. THIS INCIDENT RESULTED IN BURNS TO THE PT'S SKIN. THE CUSTOMER FURTHER REPORTS THAT THE PT RECOVERED FROM THE BURNS WITHOUT ANY MEDICAL INTERVENTION, BUT SUBSEQUENTLY DIED FROM OTHER CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129720 CADENCE ZOLL PRECONNECT DEFIBRILLATION ELECTRODES MLN COVIDIEN 22770PC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR