MAUDE Adverse Event Report: MORTARA INSTRUMENT EXCH 380 TOUCH W/ENGLISH KEYBD, LAIRD; ELECTROCARDIOGRAPH

Model Number SERV RELI380L-P-D

Device Problem 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 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 customer confirmed with technical services that all network settings were correct and that the issue was with the pcba mainboard.The customer has requested the pcba motherboard of the eli380 device to be replaced by a hillrom field service engineer.Based on this information, no further action is required at this time.If any relevant additional information becomes available it will be included in supplemental report.

Event Description

The customer reported that their eli 380 has been having an intermittent network connection issue where they are intermittently not able to sync or download the mwl.This event was captured under hillrom complaint ref # (b)(4).

• Brand Name: EXCH 380 TOUCH W/ENGLISH KEYBD, LAIRD
• Type of Device: 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: 15104767
• MDR Text Key: 302124924
• Report Number: 2183461-2022-00033
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00732094326291
• UDI-Public: 732094326291
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2022

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: SERV RELI380L-P-D
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1