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

Model Number	ELI380-DCX11
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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).
Additional 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
• Common Device Name: 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
• Report Number: 2183461-2022-00002
• Device Sequence Number: 1548080
• Product Code: DPS
• UDI-Device Identifier: 00812345026979
• UDI-Public: 812345026979
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142105
• 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,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 03/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown