BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART RATE RESPIRATION MONITOR

    MDR report key: 609470 · Received May 23, 2005

    Report

    Report Number
    2244861-2005-00007
    Event Type
    Malfunction
    Date Received
    May 23, 2005
    Date of Event
    May 5, 2005
    Report Date
    May 23, 2005
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FAMILY MEMBER COMMENTS THAT THE MONITOR TURNED OFF BY ITSELF, AND AS A RESULT THE PT WITH ACCELERATED HEART BEAT REQUIRED CPR AND HOSPITALIZATION. THE PT WAS STABILIZED AND IS PRESENTLY HOSPITALIZED.

    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 1 MO