BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CCM ARRHYTHMIA DETECTION OPTION

    MDR report key: 635948 · Received September 21, 2005

    Report

    Report Number
    1218950-2005-00303
    Event Type
    Injury
    Date Received
    September 21, 2005
    Date of Event
    August 22, 2005
    Report Date
    August 22, 2005
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A VENTRICULAR FIBRILLATION EVENT AND REQUIRED DEFIBRILLATION WHILE BEING MONITORED BY THE DEVICE. THE CENTRAL STATION DID NOT SHOW A RED ALARM.

    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 NA Life Threatening| R