BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELI380 ERGO WAM WLAN USB DICOM SEC AHA B

    MDR report key: 21625026 · Received March 17, 2025

    Report

    Report Number
    2183461-2025-00002
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    February 18, 2025
    Report Date
    March 17, 2025
    Manufacturer
    MORTARA INSTRUMENT
    Product Code
    DPS
    UDI-DI
    00812345026917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. DEVICE IS INDICATED FOR USE TO PROVIDE INTERPRETATION OF THE DATA FOR CONSIDERATION BY A PHYSICIAN. DEVICE IS INDICATED FOR USE IN A CLINICAL SETTING, BY A PHYSICIAN OR BY TRAINED PERSONNEL WHO ARE ACTING ON THE ORDERS OF A LICENSED PHYSICIAN. IT IS NOT INTENDED AS A SOLE MEANS OF DIAGNOSIS. THE INTERPRETATIONS OF ECG OFFERED BY THE DEVICE ARE ONLY SIGNIFICANT WHEN USED IN CONJUNCTION WITH A PHYSICIAN OVER-READ AS WELL AS CONSIDERATION OF ALL OTHER RELEVANT PATIENT DATA. DEVICE IS INDICATED FOR USE ON ADULT AND PEDIATRIC POPULATIONS. THE DEVICE IS NOT INTENDED TO BE USED AS A VITAL SIGNS PHYSIOLOGICAL MONITOR. THE UNIT WAS RETURNED FOR INVESTIGATION AND THE ISSUE WAS FOUND TO BE WITH THE PCBA MAIN BOARD ALTHOUGH THERE WAS NO INJURY REPORTED, IF THE ELI380 WERE TO HAVE ISSUES CONNECTING TO THE WIRELESS LAN. IT COULD LEAD TO A SERIOUS INJURY OR DEATH. THEREFORE, BAXTER IS REPORTING THIS EVENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED DEVICE IS HAVING ISSUES CONNECTING TO THE WIRELESS LAN. THIS COMPLAINT WAS CAPTURED UNDER HILLROM REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186012 ELI380 ERGO WAM WLAN USB DICOM SEC AHA B ELECTROCARDIOGRAPH DPS MORTARA INSTRUMENT ELI380-DCS11 00812345026917

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown