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

Model Number	ELI380-DCS21
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.The device was returned for inspection where it was determined that the connection problem was with the main board and the display issue was caused by the monitor wiring harness.The hrc technician replaced the corrupted main board to resolve the connection concern.Performed conformance testing and the board passed testing.The technician additionally replaced the torn/fractured monitor wiring harness, bracket and hinge covers to resolve the display concern.Reports of display issues with a eli380 would not be likely to cause or contribute to a death or serious injury if this were to recur.Therefore, hillrom does not consider reports of display issue to be a reportable event.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 alleged connection failure as a product malfunction.
Event or Problem Description
The customer reported that their eli 380 was intermittently not connecting to the network, it was additionally reported the unit had display issues.This incident was captured under hillrom complaint ref #: (b)(4).

• Brand Name: ELI380 ERGO AM12 WLAN USB DICOM SEC AHA
• 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: 17325148
• Report Number: 2183461-2023-00016
• Device Sequence Number: 6366016
• Product Code: DPS
• UDI-Device Identifier: 00812345026924
• UDI-Public: 812345026924
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/22/2023

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-DCS21
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/14/2023
• 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