BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELI

    MDR report key: 21848371 · Received April 16, 2025

    Report

    Report Number
    21848371
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 11, 2025
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    EKG [ELECTROCARDIOGRAM] MACHINE MALFUNCTION. CLIPS BROKEN, LEADS NOT CLEARLY MARKED (RUBBED OFF) AND WHEN PRINTED ONLY CAPTURED V [PRECORDIAL LEADS OR CHEST LEADS] LEADS. RT [RESPIRATORY THERAPY] CAME OVER WITH THEIR MACHINE, AND IT PRINTED AND WORKED EASILY AND QUICKLY AS IT SHOULD. PATIENT WAS STABLE, BUT IF THEY WEREN'T THIS COULD HAVE DELAYED CARE EVEN FURTHER. THIS EKG MACHINE HAS BEEN A FREQUENT PROBLEM AND EVALUATED SEVERAL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109710 ELI ELECTROCARDIOGRAPH DPS MORTARA INSTRUMENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown