MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI380 ERGO WAM WLAN USB DICOM SEC AHA B; ELECTROCARDIOGRAPH

Model Number ELI380-DCS11

Device Problem Patient Data Problem (3197)

Patient Problem Cardiac Arrest (1762)

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

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) 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 <430 ms, and <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.The exact cause of the patient¿s cardiac arrest is unknown, but likely multifactorial based on the patient¿s underlying significant cardiac history as well as qt interval prolongation which may be directly related to tikosyn plasma concentration and may cause serious ventricular arrythmias.Based on additional information from the customer that no medical decisions were made to change the course of treatment based on the ecg ¿wet read¿ by the hospitalist and the sequence of events reported to have occurred on (b)(6) 2023 (tikosyn given 0913, ecg performed 1038, cardiac arrest 1150,) 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, as the ecg was performed after the last tikosyn dose was given.If the reported event were to recur (inaccurate values populated on the cart interpretation) 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 algorithm is ongoing.If additional information becomes available following the completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

The customer reported that their eli 380 resting electrocardiograph readings were incorrect, particularly the corrected qt (qtc) value of 430, and ¿the patient subsequently went into cardiac arrest related to inappropriate tikosyn administration based on qtc measurement.¿ the customer reported that the device interpreted the patient¿s qtc value as 430 and the physician calculated the qtc value as over 500.Follow-up with the customer confirmed that there were no alterations in the patient¿s plan of care associated with the results from the ecg performed at 1038 along with the hospitalist¿s ¿wet read¿ of said ecg at that same time.Additionally, the customer reported that no subsequent prescribed doses of tikosyn were administered and that this ecg was performed, per facility practice, two hours following the last administration of tikosyn (po at 0913, q12hours) to determine if the next prescribed dose is indicated.Based on additional information from the customer that no medical decisions were made to change the course of treatment based on the ecg ¿wet read¿ by the hospitalist and the sequence of events reported to have occurred on (b)(6) 2023 (tikosyn given 0913, ecg performed 1038, cardiac arrest 1150,) 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, as the ecg was performed after the last tikosyn dose was given.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

Although multiple attempts were made to obtain the device by baxter, the customer did not return the device for investigation, therefore a thorough inspection of the device could not be performed and the root cause of the reported incident could not be established.During a follow up call, the customer asked questions related to the accuracy of the qt interval and asked for suggestions regarding their processes especially in the context of patients with potential long qt syndrome.It was made clear that algorithmic measurements from the device should only be used in the context of a physician overread and another clinical context; they should not be depended upon independently.The customer thanked us for the information we provided and indicated it would be used to refine their processes.A review of the production order for the unit was conducted and the device passed a conformity and safety test during the manufacturing process before it was shipped out to the customer.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.Follow-up with the customer confirmed that there were no alterations in the patient¿s plan of care associated with the results from the ecg performed along with the hospitalist¿s ¿wet read¿ of said ecg at that same time.Additionally, the customer reported that no subsequent prescribed doses of tikosyn were administered, and that this ecg was performed, per facility practice, two hours following the last administration of tikosyn to determine if the next prescribed dose was indicated.The investigation of the eli380 algorithm is ongoing.If additional information becomes available following the completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

The customer reported that their eli 380 resting electrocardiograph readings were incorrect, particularly the corrected qt (qtc) value of 430, and ¿the patient subsequently went into cardiac arrest related to inappropriate tikosyn administration based on qtc measurement.¿ the customer reported that the device interpreted the patient¿s qtc value as 430 and the physician calculated the qtc value as over 500.Follow-up with the customer confirmed that there were no alterations in the patient¿s plan of care associated with the results from the ecg performed at 1038 along with the hospitalist¿s ¿wet read¿ of said ecg at that same time.Additionally, the customer reported that no subsequent prescribed doses of tikosyn were administered and that this ecg was performed, per facility practice, two hours following the last administration of tikosyn (po at 0913, q12hours) to determine if the next prescribed dose is indicated.Based on additional information from the customer that no medical decisions were made to change the course of treatment based on the ecg ¿wet read¿ by the hospitalist and the sequence of events reported to have occurred on 21jul2023 (tikosyn given 0913, ecg performed 1038, cardiac arrest 1150,) 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, as the ecg was performed after the last tikosyn dose was given.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: ELI380 ERGO WAM WLAN USB DICOM SEC AHA B
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17604669
• MDR Text Key: 321813364
• Report Number: 2183461-2023-00017
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00812345026917
• UDI-Public: 812345026917
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ELI380-DCS11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female