BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCH ALLYN, INC.

    MDR report key: 19040463 · Received April 4, 2024

    Report

    Report Number
    19040463
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    October 25, 2023
    Report Date
    October 30, 2023
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ARTICULATING SCREEN ON ELI380 CAUSES THE CABLE FOR THE SCREEN FUNCTION TO FAIL. THE SCREEN NO LONGER FUNCTIONS WELL WHEN THIS HAPPENS. THIS HAS HAPPENED ON NEARLY ALL THE DEVICES IN THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2340153 WELCH ALLYN, INC. ELECTROCARDIOGRAPH DPS WELCH ALLYN, INC. ELI380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown