BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART RATE RESPIRATION MONITOR

    MDR report key: 530156 · Received March 2, 2004

    Report

    Report Number
    2244861-2004-00003
    Event Type
    Malfunction
    Date Received
    March 2, 2004
    Date of Event
    February 1, 2004
    Report Date
    March 2, 2004
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MONITOR PROVIDES A LOW AUDIO ALARM.

    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