MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI380 ERGO WAM WLAN USB DICOM IEC BAN; ELECTROCARDIOGRAPH

Model Number	ELI380-DCX12
Medical Device Problem Codes	Wireless Communication Problem (3283); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for inspection to determine a root cause of the reported malfunction.A final report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported the network and wifi were not working properly.There was no adverse event reported.
Additional Manufacturer Narrative
The device was returned for inspection where it was determined the problem was caused by a defective mainboard.The baxter technician replaced the mainboard, updated the software and performed a full functional test on the device to resolve the issue.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.Although there was no patient injury reported, if the eli 380 device loses connection to the wireless network, the device is unable to transmit or receive ekg¿s, which may result in a delay of patient treatment which could cause or contribute to a serious injury or death.Therefore, baxter is reporting this reported connection failure as a product malfunction.
Event or Problem Description
The customer reported the network and wifi were not working properly.There was no adverse event reported.

• Brand Name: ELI380 ERGO WAM WLAN USB DICOM IEC BAN
• Common Device Name: 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: 23198838
• Report Number: 2183461-2025-00018
• Device Sequence Number: 9729663
• Product Code: DPS
• UDI-Device Identifier: 00732094265200
• UDI-Public: 732094265200
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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-DCX12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 11/24/2025
• 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
• Patient Sex: Unknown