MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI380 LCD AM12 WLAN USB DICOM AHA BAN; ELECTROCARDIOGRAPH

Model Number	ELI380-ACX21
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Technical services requested that the unit be returned for repair, and gave the customer the basic service fee.The facilities biomed stated that they will meet with facility management team to discuss whether they will repair the unit or throw it away.No further information has been received at this time.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.The device has not been received for inspection, therefore a root cause into the reported issue could not be determined.Although there was no adverse event reported, if the eli 380 device loses connection to the wireless network, the device is unable to transmit or receive ecg¿s.This failed connection may result in a delay of patient treatment which may cause or contribute to a serious injury or death.Therefore, baxter is reporting this allegation of connection failure as a product malfunction.
Event or Problem Description
Baxter received a complaint from the customer reporting issues submitting orders.The wlan, custom id, and other options grey out intermittently.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: ELI380 LCD AM12 WLAN USB DICOM AHA 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: 19688450
• Report Number: 2183461-2024-00019
• Device Sequence Number: 20817259
• Product Code: DPS
• UDI-Device Identifier: 00812345024562
• UDI-Public: 812345024562
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/08/2024

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-ACX21
• 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: 06/13/2024
• Initial Report FDA Received Date: 07/08/2024
• 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