BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART RATE RESPIRATION MONITOR

    MDR report key: 489566 · Received October 8, 2003

    Report

    Report Number
    2244861-2003-00016
    Event Type
    Malfunction
    Date Received
    October 8, 2003
    Date of Event
    September 1, 2003
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTS THE USERS CLAIM THAT THE MONITOR SHUT DOWN WHILE IN USE ON A PT. THE PT WAS NOT HARMED.

    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