BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELI380 ERGO WAM WLAN USB DICOM SEC AHA B

    MDR report key: 19219343 · Received May 1, 2024

    Report

    Report Number
    2183461-2024-00014
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 3, 2024
    Report Date
    July 12, 2024
    Manufacturer
    MORTARA INSTRUMENT
    Product Code
    DPS
    UDI-DI
    00812345026917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE HRC TECHNICIAN REMOTELY INVESTIGATED THE REPORTED EVENT BUT WAS NOT ABLE TO REPRODUCE THE ISSUE. HILLROM IS SENDING THE HRC TECHNICIAN ON SITE TO FURTHER INVESTIGATE THE REPORTED MALFUNCTION. HILLROM WILL SUBMIT A SUPPLEMENTAL REPORT WITH FINDINGS ONCE THE ON SITE REPAIR HAS BEEN COMPLETED. ALTHOUGH THERE WAS NO PATIENT HARM REPORTED IN THIS CASE, AN INCORRECT ASSOCIATION OF ECG RECORDS WITH WRONG PATIENT CHARTS COULD LEAD TO MISDIAGNOSIS AND/OR MISTREATMENT WHICH COULD ULTIMATELY LEAD TO PATIENT HARM, THEREFORE, HILLROM CONSIDERS THIS COMPLAINT REPORTABLE.

    Additional Manufacturer Narrative · 0

    DURING FOLLOW UP IT WAS NOTED THAT TECH WOULD SELECT THE NECESSARY PATIENT IN THE MWL TO PERFORM A RESTING ECG. INTERMITTENTLY THE ELI380 WITH SPORADICALLY BEEP AND EACH TIME IT BEEPS IT WILL CHOOSE A DIFFERENT PATIENT FROM THE MODALITY WORKLIST FOR THE DEMOGRAPHIC INFORMATION. IN AN EXAMPLE IT CYCLED THROUGH 8-10 PATIENTS OVER 5 SECONDS. THIS RESULTS IN ECG BEING TAKEN ON PATIENT A BUT THE DEMOGRAPHICS ON THE ECG WILL SHOW PATIENT B, EVEN THOUGH PATIENT A WAS SELECTED FROM THE MODALITY WORKLIST. CUSTOMER CALLED IN WITH ADDITIONAL INFORMATION REPORTING THAT THE ISSUE WAS HAPPENING ONLY ON NEW ELI380 UNITS WITH THE SOFTWARE VERSION OF 2.6.1.1 WITH MWL IN USE. THE ISSUE DID NOT SEEM TO HAPPEN WHEN PATIENT DEMOGRAPHICS WERE ENTERED MANUALLY OR ON OLDER SOFTWARE VERSIONS. A FIELD INSPECTION WAS NOT ABLE TO BE PERFORMED AT THIS FACILITY HOWEVER LOG FILES WERE OBTAINED FOR REVIEW WHICH SHOWED NO ABNORMALITIES.. DEVICE HISTORY REVIEW WAS PERFORMED WHERE NO MANUFACTURING ISSUES WERE NOTED. RISK FILE REVIEW WAS ALSO PERFORMED WHERE IT WAS DETERMINED THAT THE RISK WAS ADEQUATELY COVERED FOR THIS SCENARIO. 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 ELI380 USER MANUAL ON PAGE 65 GIVES INSTRUCTIONS FOR DIFFERENT METHODS OF ENTERING PATIENT DEMOGRAPHICS. ALTHOUGH THERE WAS NO DEVICE MALFUNCTION CONFIRMED, THE SITUATION WILL CONTINUE TO BE MONITORED. AN INCORRECT ASSOCIATION OF ECG RECORDS WITH WRONG PATIENT CHARTS COULD LEAD TO MISDIAGNOSIS AND/OR MISTREATMENT WHICH COULD ULTIMATELY LEAD TO PATIENT HARM, THEREFORE, HILLROM CONSIDERS THIS COMPLAINT REPORTABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ECG RECORDS WERE JUMPING TO DIFFERENT INCORRECT PATIENTS ON THE ELI380 CARTS. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ECG RECORDS WERE JUMPING TO DIFFERENT INCORRECT PATIENTS ON THE ELI380 CARTS. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143834 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