MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ELI 380; Electrocardiograph

Catalog Number	ELI380-DCS11
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that an eli380 had a burn mark above the touchpad on the top right.This occurred before use.There was no patient injury or death reported with this event.
Additional Manufacturer Narrative
The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

• Brand Name: ELI 380
• Common Device Name: Electrocardiograph
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): WELCH ALLYN PRODUCTS, MEXICO; emilio flores #2471-a2; caã¿â¿¿on del padre; tijuana, baja california NA 22203 ; MX 22203
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50263556
• Report Number: 3006087789-2026-00015
• Device Sequence Number: 10316550
• Product Code: DPS
• UDI-Device Identifier: 00812345026917
• UDI-Public: (01)00812345026917
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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 Catalogue Number: ELI380-DCS11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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