BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECON ELI 380 TOUCH ASSY W/ENGLISH KEYBD

    MDR report key: 23802990 · Received December 15, 2025

    Report

    Report Number
    2183461-2025-00024
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 15, 2025
    Manufacturer
    MORTARA INSTRUMENT
    Product Code
    DPS
    UDI-DI
    00732094273885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR INSPECTION. THE DEVICE WAS ABLE TO DOWNLOAD A MWL AND TRANSMIT A RECORD AND WAS ABLE TO TAKE THE CONNECTED WAM 10FT AWAY FROM THE DEVICE AND IT STAY CONNECTED. TECHNICIAN THEN TOOK THE DEVICE ACROSS THE ROOM AND IT STAYED CONNECTED AND WAS ALSO ABLE TO TRANSMIT A TEST RECORD. THE DEVICE WAS PUT INTO A SIMULATION MODE, NO ISSUES WERE FOUND WITH THE DEVICE CONNECTION. THE ELI 380 IS INTENDED TO BE A HIGH-PERFORMANCE, MULTICHANNEL RESTING ELECTROCARDIOGRAPH. AS A RESTING ELECTROCARDIOGRAPH, THE ELI 380 SIMULTANEOUSLY ACQUIRES DATA FROM EACH LEAD. ONCE THE DATA IS ACQUIRED, IT CAN BE ANALYZED, REVIEWED, STORED, PRINTED OR TRANSMITTED. IT IS A DEVICE PRIMARILY INTENDED FOR USE IN HOSPITALS BUT MAY BE USED IN MEDICAL CLINICS AND OFFICES OF ANY SIZE. ALTHOUGH THERE WAS NO PROBLEM FOUND WITH THE DEVICE DURING INSPECTION AND A ROOT CAUSE COULD NOT BE DETERMINED, IF THE ELI380 WERE TO DROP CONNECTION DURING URGENT MONITORING, IT COULD LEAD TO SERIOUS INJURY OR DEATH. BAXTER IS CAUTIOUSLY REPORTING THIS COMPLAINT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE DEVICE WAS CONSTANTLY DROPPING FROM THE NETWORK. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291711 RECON ELI 380 TOUCH ASSY W/ENGLISH KEYBD ELECTROCARDIOGRAPH DPS MORTARA INSTRUMENT SERV RELI380-P-D 00732094273885

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown