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

Model Number ELI380-DCS11

Device Problems Display Difficult to Read (1181); Intermittent Communication Failure (4038)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 a monitor is not readable or difficult to read the results the user would question the integrity of the device and would likely remove it from clinical use until it was repaired or replaced.If the eli 380 device loses connection 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.The hillrom technician found the cable between the display and motherboard to be the cause of the display issue and the cable was replaced to correct the reported issue.A software upgrade was performed to resolve the disconnect issue.Based on this information, no further action is required at this time.

Event Description

The customer reported that their eli 380's screen would turn purple and blurry when opened.They also said there is intermittent network communication issues.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: ELI380 ERGO WAM WLAN USB DICOM SEC AHA B
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: sarah oreilly ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 14039863
• MDR Text Key: 289885514
• Report Number: 2183461-2022-00011
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00812345026917
• UDI-Public: 812345026917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2022

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-DCS11
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1