BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART RATE RESPIRATION MONITOR

    MDR report key: 512280 · Received January 14, 2004

    Report

    Report Number
    2244861-2004-00002
    Event Type
    Malfunction
    Date Received
    January 14, 2004
    Date of Event
    December 1, 2003
    Report Date
    January 14, 2004
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL REPORTS THAT THE AUDIO ALARM IS VERY LOW AND NOT WITHIN THE SPECIFICATION PER THE USER MANUAL.

    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