BEUDAMED
    FDA Adverse Event Death Summary report: N

    1310P MEDITRACE 2/PK 20/CA

    MDR report key: 1414604 · Received July 14, 2009

    Report

    Report Number
    9681860-2009-00010
    Event Type
    Death
    Date Received
    July 14, 2009
    Date of Event
    June 2, 2009
    Report Date
    June 11, 2009
    Manufacturer
    COVIDIEN
    Product Code
    MLN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 06/11/2009 THAT A CUSTOMER HAD A PROBLEM WITH A DEFIBRILLATION ELECTRODE. THE CUSTOMER REPORTS DEFIBRILLATION WAS ATTEMPTED ON PATIENT IN FULL CARDIAC ARREST AND PADS FAILED TO SHOCK. THE PATIENT WAS GIVEN ADDITIONAL CODE BLUE RESPONSE BY THE FIRE DEPARTMENT AND THE PATIENT'S CONDITION WAS UNCHANGED AND THE PT EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death