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

Model Number ELI380-DCX11

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/23/2021

Event Type  Injury  

Manufacturer Narrative

The eli 380 is intended to be a high-performance, multichannel resting electrocardiograph.As a resting electrocardiograph, the eli 380 simultaneously acquires data from each lead.Once the data is acquired, it can be analyzed, reviewed, stored, printed, or transmitted.It is a device primarily intended for use in hospitals but may be used in medical clinics and offices of any size.This event is considered a reportable malfunction in combination with user error which led to an invasive procedure (serious injury).No further information is available on the device at this time.Additional information has been requested including ecg print outs and log files to verify whether warnings were displayed regarding lead reversal and if malfunction of the device occurred.Hillrom will submit a final report with investigation conclusion on this incident.

Event Description

Hillrom received a report from the account stating lead reversal of an eli 380 and a patient having delayed care and unnecessary medication/treatment because of the error.Hillrom has requested further information from the customer regarding the incident as part of the investigation.This report was filed in our complaint handling system as complaint #:(b)(4).

Event Description

Hillrom received a report from the account stating lead reversal of an eli 380 and a patient having delayed care and unnecessary medication/treatment because of the error.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The eli 380 is intended to be a high-performance, multichannel resting electrocardiograph.As a resting electrocardiograph, the eli 380 simultaneously acquires data from each lead.Once the data is acquired, it can be analyzed, reviewed, stored, printed, or transmitted.It is a device primarily intended for use in hospitals but may be used in medical clinics and offices of any size.This event is considered a reportable malfunction in combination with user error which led to an invasive procedure (serious injury).No additional information was provided regarding ecg print outs and log files to verify whether warnings were displayed regarding lead reversal and if malfunction of the device occurred.Should additional information be provided, a supplemental report will be filed.

• 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
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 13314101
• MDR Text Key: 284173151
• Report Number: 2183461-2022-00002
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00812345026979
• UDI-Public: 812345026979
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ELI380-DCX11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization