BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART RATE RESPIRATION MONITOR

    MDR report key: 706393 · Received June 15, 2005

    Report

    Report Number
    2244861-2005-00008
    Event Type
    Malfunction
    Date Received
    June 15, 2005
    Date of Event
    May 1, 2005
    Report Date
    June 15, 2005
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOME CARE DEALER REPORTS THAT MONITOR IS NOT RELAYING AN ALARM SIGNAL TO THE REMOTE ALARM BOX OR THAT THE REMOTE ALARM BOX IS NOT WORKING.

    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 NA