BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCH ALLYN, INC.

    MDR report key: 10008965 · Received April 29, 2020

    Report

    Report Number
    10008965
    Event Type
    Malfunction
    Date Received
    April 29, 2020
    Date of Event
    February 20, 2020
    Report Date
    April 21, 2020
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SHUTS OFF ALL THE TIME, FALSE READINGS, TURNS OFF MID-TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474903 WELCH ALLYN, INC. THERMOMETER, ELECTRONIC, CLINICAL FLL WELCH ALLYN, INC. 901053

    Patients

    Seq Age Sex Outcome Treatment
    1