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

Model Number	ELI380-ACX11
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the eli 380 was having roaming issues with wifi.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
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.· 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.Remote troubleshooting into the reported issue, determined that the issue was likely due to a faulty radio card.The customer will order a replacement radio card to resolve the issue.Based on this information, no further actions are necessary at this time.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, hillrom is reporting this connection failure as a product malfunction.

• Brand Name: ELI380 LCD WAM WLAN USB DICOM AHA BAN
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: daniela avila ; 7865 n 86th street; milwaukee, WI 53224 ; 8129310130
• MDR Report Key: 19108687
• Report Number: 2183461-2024-00011
• Device Sequence Number: 12722694
• Product Code: DPS
• UDI-Device Identifier: 00812345024531
• UDI-Public: 812345024531
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 04/15/2024

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-ACX11
• 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: 04/03/2024
• Initial Report FDA Received Date: 04/15/2024
• 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
• Patient Sex: Unknown