BEUDAMED
    FDA Adverse Event Death Summary report: N

    CCM ARRHYTHMIA DETECTION OPTION

    MDR report key: 378126 · Received February 22, 2002

    Report

    Report Number
    1218950-2002-00028
    Event Type
    Death
    Date Received
    February 22, 2002
    Date of Event
    January 24, 2002
    Report Date
    January 25, 2002
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DID NOT ALARM WHEN THE HEART RATE EXCEEDED THE SET LIMITS.

    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 UNKNOWN Death