BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCH ALLYN, INC.

    MDR report key: 14929018 · Received July 6, 2022

    Report

    Report Number
    14929018
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    June 15, 2022
    Report Date
    July 1, 2022
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERMOMETER READINGS WERE CONSISTENTLY 2 DEGREES CELSIUS HIGHER THAN THE ACTUAL TEMPERATURE. THE ERROR WAS FOUND WHEN ANOTHER THERMOMETER WAS USED AND PROVIDED THE ACCURATE READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449510 WELCH ALLYN, INC. THERMOMETER, ELECTRONIC, CLINICAL FLL WELCH ALLYN, INC. 901053

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DA Male