BEUDAMED
    FDA Adverse Event Death Summary report: N

    1310P MEDITRACE 2/PK 20/CA

    MDR report key: 705298 · Received April 27, 2006

    Report

    Report Number
    9681860-2006-00002
    Event Type
    Death
    Date Received
    April 27, 2006
    Date of Event
    March 28, 2006
    Report Date
    March 30, 2006
    Manufacturer
    TYCO/KENDALL HEALTHCARE
    Product Code
    LDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER HAD A PROBLEM WITH THE MEDITRACE DEFIBRILLATION PADS. THE CUSTOMER STATES THAT THE MALE PATIENT WAS IN CARDIAC ARREST. EVENT OCCURRED ON MARCH 28, 2006. THEY TRIED TO DELIVER SHOCK, HOWEVER WHEN CONNECTED TO THE MACHINE, THEY KEPT GETTING A "CONNECT ELECTRODES" MESSAGE AT THE PROMPT. FOLLOWING THIS, THE AMBULANCE TOOK THE PATIENT TO THE HOSPITAL. THE FIRE DEPARTMENT HAD NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1310P MEDITRACE 2/PK 20/CA DEFIBRILLATION PADS LDD TYCO/KENDALL HEALTHCARE 31319281 531417

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death