BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART RATE RESPIRATION MONITOR

    MDR report key: 592969 · Received April 14, 2005

    Report

    Report Number
    2244861-2005-00004
    Event Type
    Malfunction
    Date Received
    April 14, 2005
    Date of Event
    March 1, 2005
    Report Date
    April 14, 2005
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MONITOR IS GIVING A WEAK ALARM SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART RATE RESPIRATION MONITOR BREATHING FREQUENCY MONITOR FLS CAS MEDICAL SYSTEMS, INC. 511 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN