BEUDAMED
    FDA Adverse Event Death Summary report: N

    CCM ARRHYTHMIA DETECTION OPTION

    MDR report key: 385235 · Received March 28, 2002

    Report

    Report Number
    1218950-2002-00050
    Event Type
    Death
    Date Received
    March 28, 2002
    Date of Event
    February 28, 2002
    Report Date
    March 1, 2002
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM RECORDED A "LEADS OFF" ALARM WHILE THE PATIENT WAS BEING MONITORED. ACCORDING TO A CLINICIAN, THE USER HAD ACKNOWLEDGED THIS CONDITION. THE PATIENT WAS FOUND DEAD ON THE FLOOR WITH ECG ELECTRODES STILL ATTACHED TO THE SKIN. HOWEVER, THE ECG CABLE WAS DISCONNECTED FROM THE ELECTRODES BUT STILL CONNECTED TO THE BEDSIDE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CCM ARRHYTHMIA DETECTION OPTION CCM ARRHYTHMIA DETECTION DRT AGILENT TECHNOLOGIES, INC. M2350A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death