BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART RATE RESPIRATION MONITOR

    MDR report key: 486518 · Received September 24, 2003

    Report

    Report Number
    2244861-2003-00015
    Event Type
    Malfunction
    Date Received
    September 24, 2003
    Date of Event
    August 1, 2003
    Report Date
    September 24, 2003
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MONITOR'S AUDIO ALARM IS NOT WORKING ALL THE TIME.

    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 UNKNOWN