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

Model Number ELI380-DCX11

Device Problems Disconnection (1171); Wireless Communication Problem (3283)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2020

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 the eli 380 device loses connection to the wireless network, the device is unable to transmit or receive ekg¿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.No further information is available on the repair of the device at this time.The investigation is ongoing and the investigation and resolution details will be submitted in a supplemental report.

Event Description

Hillrom received a report from the account stating that the eli 380 device would lose connection to the network.The device was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The customer was provided with the upgraded software version v2.4.3 and installation instructions of the eli380 device to correct the reported issue.The customer installed the new software version and the device is functioning as designed.Based on this information, no further action is required at this time.

Event Description

Hillrom received a report from the account stating that the eli 380 device would lose connection to the network.The device was located at the account.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 AHA BAN
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• MDR Report Key: 11154994
• MDR Text Key: 250229092
• Report Number: 2183461-2021-00002
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00812345026979
• UDI-Public: 812345026979
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ELI380-DCX11
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1