BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELI380 ERGO WAM WLAN USB DICOM PDQ IEC B

    MDR report key: 10920542 · Received November 30, 2020

    Report

    Report Number
    2183461-2020-00033
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Date of Event
    November 5, 2020
    Report Date
    November 30, 2020
    Manufacturer
    MORTARA INSTRUMENT
    Product Code
    DPS
    UDI-DI
    00732094301670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELI 380 DEVICE IS INDICATED FOR USE TO ACQUIRE, ANALYZE, DISPLAY, AND PRINT ELECTROCARDIOGRAMS. 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. IF THE ELI 380 DEVICE LOSES CONNECTION TO THE WIRELESS NETWORK, THE DEVICE IS UNABLE TO TRANSMIT OR RECEIVE EKG¿S. THIS FAILED CONNECTION MAY RESULT IN A DELAY OF PATIENT TREATMENT WHICH MAY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. THEREFORE, (B)(4) IS REPORTING THIS ALLEGED CONNECTION FAILURE AS A PRODUCT MALFUNCTION. THE SOFTWARE OF THE ELI380 DEVICE WAS UPGRADED TO A NEW SOFTWARE VERSION TO CORRECT THE REPORTED ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    (B)(4) RECEIVED A REPORT FROM THE ACCOUNT STATING THAT THE ELI 380 DEVICE WOULD DROP CONNECTION TO THE WIRELESS NETWORK. THE DEVICE WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384898 ELI380 ERGO WAM WLAN USB DICOM PDQ IEC B ELECTROCARDIOGRAPH DPS MORTARA INSTRUMENT ELI380-DCP12 00732094301670

    Patients

    Seq Age Sex Outcome Treatment
    1