BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART RATE RESPIRATION MONITOR

    MDR report key: 650945 · Received December 7, 2005

    Report

    Report Number
    2244861-2005-00012
    Event Type
    Death
    Date Received
    December 7, 2005
    Date of Event
    October 27, 2005
    Report Date
    December 6, 2005
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE ANALYSIS OF THE MEMORY DOWNLOAD SHOWS LITTLE OR NO CAREGIVER RESPONSE TO AN ALARMING MONITOR AT THE TIME WHEN THE EVENTS LEADING UP TO DEATH WERE HAPPENING. PT DIED AFTER A SERIES OF BRADYCARDIA AND APNEA EVENTS BEGAN AT 00:17 IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART RATE RESPIRATION MONITOR BREATHING FREQUENCY MONITOR FLS CAS MEDICAL SYSTEMS, INC. 9700B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Death