BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELI380 ERGO WAM WLAN USB DICOM SEC AHA B

    MDR report key: 23642927 · Received November 25, 2025

    Report

    Report Number
    2183461-2025-00021
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 25, 2025
    Manufacturer
    MORTARA INSTRUMENT
    Product Code
    DPS
    UDI-DI
    00812345026917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP WAS PERFORMED WITH THE CUSTOMER, AND THE CUSTOMER STATED THIS EVENT WAS NOT RELATED TO THE EKG. THE CUSTOMER REPORTED THAT NO ONE REALIZED THE CORRECTED QT INTERVAL WAS NOT SET TO QTCB BAZETT¿S FORMULA SO THERE WAS NO CALCULATION FOR THE QTB. THE CUSTOMER CONFIRMED THAT THERE WERE NO ALTERATIONS IN THE PATIENT¿S PLAN OF CARE ASSOCIATED WITH THE RESULTS FROM THE ECG PERFORMED AND THAT THE TIKOSYN WOULD HAVE STILL BEEN ADMINISTERED AS THE REAL READING WAS ABOVE 501. THE CUSTOMER REPORTED THAT THE EVENT OCCURRED DUE TO SUPPLEMENTS (NAME OF SUPPLEMENTS WAS NOT PROVIDED) THE PATIENT WAS TAKING AND THE PHYSICIAN ORDERING THE TIKOSYN TOO CLOSELY TOGETHER. THE COMBINATION OF TIKOSYN ADMINISTRATION AND THE SUPPLEMENTS THE PATIENT WAS TAKING WAS REPORTED TO HAVE CAUSED AN ABNORMAL HEARTBEAT, TORSADE DE POINTES, RESULTING IN CARDIAC ARREST. ADDITIONAL DETAILS REGARDING THE PATIENT¿S MEDICAL HISTORY AND OUTCOME WERE ASKED; HOWEVER, NO ADDITIONAL DETAILS WERE PROVIDED. THE ELI 380 DEVICE IS INTENDED TO BE USED TO ACQUIRE, ANALYZE, DISPLAY, AND PRINT ELECTROCARDIOGRAMS TO PROVIDE INTERPRETATION OF THE DATA FOR CONSIDERATION BY A PHYSICIAN. THE DEVICE IS INTENDED TO BE USED 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 IFU STATES 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. THE ELI 380 DEVICE USES THE BAZETT¿S FORMULA FOR CALCULATING THE QTC VALUE (WHEN ENABLED IN THE DEVICE CONFIGURATION SETTINGS; THIS IS NOT SET ON DEFAULT) WHICH IS CALCULATED BY DIVIDING THE QT INTERVAL BY THE SQUARE ROOT OF THE RR INTERVAL IN A PATIENT¿S ECG. THE QTC ESTIMATES THE QT INTERVAL AT A HEART RATE OF 60BPM, THIS ALLOWS COMPARISON VALUES OVER TIME AT DIFFERENT HEART RATES AND IMPROVES DETECTION OF ARRHYTHMIAS. THE NORMAL QTC RANGE FOR AN ADULT MALE IS LESS THAN 430 MS, AND LESS THAN 460 MS FOR AN ADULT FEMALE. CARDIAC ARREST IS THE LOSS OF ALL HEART ACTIVITY, CAUSING LOSS OF BLOOD FLOW, UNCONSCIOUSNESS, AND POSSIBLY DEATH. COMMON CONDITIONS THAT LEAD TO CARDIAC ARREST ARE VENTRICULAR FIBRILLATION, CORONARY ARTERY DISEASE, HEART ATTACK, CARDIOMYOPATHY, HEART VALVE DISEASE, OR CONGENITAL HEART DEFECTS. IN THIS EVENT, THE PATIENT WAS REPORTED TO HAVE EXPERIENCED A LIFE-THREATENING CARDIAC ARREST REQUIRING EMERGENT MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OR DEATH, CONCLUDING A SERIOUS INJURY OCCURRED. THE EXACT CAUSE OF THE PATIENT¿S CARDIAC ARREST IS UNKNOWN, BUT LIKELY MULTIFACTORIAL BASED ON THE CUSTOMER¿S REPORT OF SUPPLEMENTS THE PATIENT WAS TAKING AND TIKOSYN BEING ORDERED AND ADMINISTERED TOO CLOSELY TOGETHER. BASED ON ADDITIONAL INFORMATION FROM THE CUSTOMER THAT NO MEDICAL DECISIONS WERE MADE TO CHANGE THE COURSE OF TREATMENT BASED ON THE ECG READING IT IS REASONABLE TO CONCLUDE THAT THE INACCURATE QT/QTC VALUES PROVIDED BY THE ELI 380 DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S CARDIAC ARREST. IF THE REPORTED USE ERROR EVENT WERE TO RECUR OF INACCURATE VALUES DUE TO ECG SETTINGS NOT CONFIGURED AND VERIFIED TO THE EXPECTED FORMULA AND A TRAINED CLINICIAN OVER-READ DOES NOT OCCUR, IT IS LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY, HOWEVER, THE IMPORTANCE OF PHYSICIAN OVER-READ IS OUTLINED AS NOTED ABOVE IN THE IFU. THE INVESTIGATION OF THE ELI380 IS ONGOING THE DEVICE WAS RETURNED AND IS PENDING INSPECTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT THE ELI 380 RESTING ELECTROCARDIOGRAPH READINGS WERE MISCALCULATING THE QTC AND THE PATIENT WENT INTO CARDIAC ARREST. THE CUSTOMER REPORTED THAT THE DEVICE INTERPRETED THE PATIENT¿S QTC VALUE AS 440 AND THE PHYSICIAN CALCULATED THE QTC VALUE AS 501.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2830252 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 Required Intervention