BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELI 380

    MDR report key: 20310396 · Received September 26, 2024

    Report

    Report Number
    20310396
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 5, 2024
    Report Date
    September 5, 2024
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    DPS
    UDI-DI
    00812345026924
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    THE EKG UNIT SCREEN IS SUPPORTED BY A HINGE THAT SUPPORTS THE DISPLAY TO OPEN AND CLOSE. THIS HINGE IS GETTING CRACKED ON VARIOUS POINTS AND IS PREVENTING THE DISPLAY TO LIGHT UP TO SHOW THE PATIENT EKG. THIS HAS BEEN EXPERIENCED ON A COUPLE OF OUR UNITS SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263603 ELI 380 ELECTROCARDIOGRAPH DPS WELCH ALLYN, INC. ELI380-DCXXX 00812345026924

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown