BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART RATE RESPIRATION MONITOR

    MDR report key: 601847 · Received May 5, 2005

    Report

    Report Number
    2244861-2005-00006
    Event Type
    Malfunction
    Date Received
    May 5, 2005
    Date of Event
    March 1, 2005
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTS THAT THE DISPLAYED VALUES FROOZE WITHOUT CHANGING AND THE MONTIOR DID NOT 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