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

Model Number	ELI380-DCS11
Medical Device Problem Code	Failure to Transmit Record (1521)
Health Effect - Clinical Codes	Arrhythmia (1721); Myocarditis (2470)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the use of the eli 380, the device would not print and displayed a paper queue fault error.The customer reported the patient had been admitted for abnormal heart rate and myocarditis and at the time of the event the patient was noted to be bradycardic.A code was initiated, and an ecg was requested.At that time the eli 380 did not print.Therefore, a staff member obtained an alternate ecg device from a neighboring area, thus resulting in a 3-minute delay in obtaining the alternate device and identifying that the patient was in 2nd degree heart block, which could not be identified on the facility¿s 3rd party monitoring device.Similarly, it was reported that prior to obtaining the alternate device, based on the patient¿s clinical status, the decision was made to quickly transfer the patient to a higher level of care, including the cardiac catheterization lab and icu.The customer confirmed that no injury occurred, however, indicated that a delay in care and clinical decision making occurred as a result of this event.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
The eli 380 is indicated to acquire, analyze, display and print electrocardiograms.The device provides interpretation of the date for consideration by a physician and is not intended as a sole means of diagnosis.The device instructions for use states: the interpretation 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 data.Upon connection of the patient to the device, the patient¿s ecg waveform is displayed in real-time on the device¿s 17 color display.The configuration selections of the device allow the clinician to turn the ecg interpretation statements on/off for presentation on the display and/or a printed report.The device outlines the steps in the event of a paper queue fault which includes: add paper, manually advance page evenly past closure point of writer and closer writer cover.An inspection of the device performed by a baxter technician noted that the device functioned as designed, passing a functional test.The inspection noted that the allegation could not be duplicated.In this incident, the customer confirmed that no injury occurred.Although the device did not print, the patient¿s ecg and interpretation is displayed on the device¿s color screen.In settings where an emergent ecg may be necessary, a back-up device is expected to be readily available.Furthermore, the clinician would utilize their critical judgement based on the patient¿s signs, symptoms and status, in determining the best appropriate care for the patient at that time (as in this case), thus if the reported event were to recur, device would not print resulting in a delay in care, a serious injury or death is unlikely.However, the report of the 3-minute delay in this event is considered temporarily life-threatening due to the delay in critical care and this patient¿s clinical scenario, indicating a serious injury occurred.The cause of the device¿s failure to prints is unknown, however the inspection ruled out a device malfunction.Based on this information, no further action is required.

• Brand Name: ELI380 ERGO WAM WLAN USB DICOM SEC AHA B
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: daniela avila ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 20686202
• Report Number: 2183461-2024-00042
• Device Sequence Number: 8584641
• Product Code: DPS
• UDI-Device Identifier: 00812345026917
• UDI-Public: (01)00812345026917
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ELI380-DCS11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown