BEUDAMED
    FDA Adverse Event Death Summary report: N

    1310P MEDITRACE 2/PK 20/CA

    MDR report key: 2132271 · Received June 14, 2011

    Report

    Report Number
    9681860-2011-00002
    Event Type
    Death
    Date Received
    June 14, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    COVIDIEN
    Product Code
    DRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(6) 2011. 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)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH 4 PAIRS OF (B)(4) DEFIBRILLATION ELECTRODES. THE CUSTOMER REPORTED THAT THE PT CAME TO THE EMERGENCY ROOM IN FULL CARDIAC ARREST, AND THE PT HAD TO BE DEFIBRILLATED. THE CUSTOMER PLACED 4 DIFFERENT PAIRS OF ELECTRODES ON THE PT AND ALL 4 DID NOT READ IN THE EQUIPMENT. THE EQUIPMENT STATED TO "ATTACH ELECTRODES" WHEN THE ELECTRODES WERE ALREADY ATTACHED TO THE PT AND TO THE EQUIPMENT. THE CUSTOMER HAD TO USE PADDLES ON THE PT TO DEFIBRILLATE, BUT THE PT EXPIRED. THE EQUIPMENT WAS LATER TESTED BY THEIR BIOMED DEPARTMENT AND THE CUSTOMER CONFIRMED THAT THERE WERE NO ISSUES WITH THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1310P MEDITRACE 2/PK 20/CA DEFIBRILLATION ELECTRODES DRX COVIDIEN 31319281 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death