BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART RATE RESPIRATION MONITOR

    MDR report key: 623351 · Received July 28, 2005

    Report

    Report Number
    2244861-2005-00009
    Event Type
    Death
    Date Received
    July 28, 2005
    Date of Event
    June 12, 2005
    Report Date
    July 28, 2005
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PREMATURE BABY WITH A BRAIN INJURY AT BIRTH PASSED AWAY AFTER ATTEMPTS AT CPR BY PARENT AND EMS WERE UNSUCESSFUL. MONITOR WAS NOT OPERATING AT THE TIME AND WAS NOT IMPLICATED IN THE BABIE'S DEATH. RECORDED INFORMATION FROM THE MONITOR CLEARLY SHOWS CORRECT OPERATION ONCE THE MONITOR WAS RESTARTED.

    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 34 * Death