MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI280 AM12 IEC BAN LAN USBD; ELECTROCARDIOGRAPH

Model Number	ELI280-BDB-AACBX
Medical Device Problem Codes	Data Problem (3196); Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device inspection is pending, the investigation is currently on going.The eli 280 is intended to be a high-performance, 12-lead, multifunctional electrocardiograph.As a resting electrocardiograph, eli 280 simultaneously acquires data from 12 leads.Once the data is acquired, it can be reviewed and/or stored, and/or printed.It is a device primarily intended for use in hospitals but may be used in medical clinics and offices of any size.A final report will be submitted with investigation findings upon completion.
Event or Problem Description
The customer reported that the ecg is transferred with incorrect demographic data.There was no adverse event reported.This incident has been captured under complaint ref #:(b)(4).
Event or Problem Description
The customer reported that the ecg is transferred with incorrect demographic data there was no adverse event reported.This incident has been captured under complaint ref#(b)(4).
Additional Manufacturer Narrative
The field technician inspected the unit and performed all equipment checks as per procedure, where it was determined that the device had an incorrect date configuration due to incorrect configuration settings.The configuration settings were corrected to fix the reported issue and the unit was working as intended.The eli 280 is intended to be a high-performance, 12-lead, multifunctional electrocardiograph.As a resting electrocardiograph, eli 280 simultaneously acquires data from 12 leads.Once the data is acquired, it can be reviewed and/or stored, and/or printed.It is a device primarily intended for use in hospitals but may be used in medical clinics and offices of any size.There was no adverse event associated with the reported malfunction and if the unit were to give an incorrect date on the report as a result of use error from incorrect device settings it would be unlikely to result in patient injury.It is not likely that the clinician would incorrectly treat the patient from historical data.Live patient monitoring and alarm functionality would not be affected.Other means of diagnosis are available to the clinician.After consideration for potential harms and worst-case scenarios, no serious adverse health consequence would occur from this issue.Baxter does not consider this to be a reportable malfunction.

• Brand Name: ELI280 AM12 IEC BAN LAN USBD
• Common Device Name: 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: 20566052
• Report Number: 2183461-2024-00041
• Device Sequence Number: 20790541
• Product Code: DPS
• UDI-Device Identifier: 00732094267013
• UDI-Public: 732094267013
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: ELI280-BDB-AACBX
• Was Device Available for Evaluation?: Yes
• 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: 10/04/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown