BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS MONITOR 300 SERIES

    MDR report key: 4143251 · Received September 26, 2014

    Report

    Report Number
    4143251
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 26, 2014
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    REMOVED THERMOMETER PROBE AND UNIT ALARMED DISPLAYING ERROR MESSAGE C20 THEN SHUT OFF. BIOMED NOTIFIED. LABEL ON SIDE OF UNIT STATES CODE C20 MEANS TEMP PROBE FAILURE. BIOMED REPLACED THERMOMETER PROBE AND ERROR MESSAGE WENT AWAY. FUNCTIONAL TEST COMPLETED AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600615 VITAL SIGNS MONITOR 300 SERIES MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION O MWI WELCH ALLYN PROTOCOL, INC. 300 SERIES *

    Patients

    Seq Age Sex Outcome Treatment
    1 *