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

Model Number	ELI380-DCX21
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.If the eli 380 device does not connect to the wireless network, the device is unable to transmit or receive ekg¿s.Based on an analysis of the risk file, a failed connection on an eli380 may result in a delay of patient treatment which may cause or contribute to a serious injury or death.Therefore, hillrom is reporting this alleged connection failure as a product malfunction.Technical phone assistance was provided.It settings were reviewed.Reload of firmware by hard reset was recommended.Wireless network issues were resolved.Based on this information, no further action is required at this time.
Event or Problem Description
It was reported that the eli380 failed to connect to the network.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: ELI380 ERGO AM12 WLAN USB DICOM AHA BAN
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 14276846
• Report Number: 2183461-2022-00016
• Device Sequence Number: 17548223
• Product Code: DPS
• UDI-Device Identifier: 00812345026986
• UDI-Public: 812345026986
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2022

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-DCX21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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