MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI280 AM12 AHA BAN WLAN USBD DICOM; ELECTROCARDIOGRAPH

Model Number	ELI280-AAA-AAFBD
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.During troubleshooting with the customer it was additionally determined that when the "wrong" patient had two orders available in the emr, the cart would have had two open orders for the "wrong" patient.The "wrong" patient was seen first and had an ecg obtained against one of those two orders, which worked correctly.This left one order still unused for that patient.Then, from a different cart the "right" patient had their ecg done when it linked to "wrong" patient info.At this time the cause of the reported issue is undetermined.The investigation is currently on going, any relevant findings will be submitted in a supplemental report.
Event or Problem Description
The customer reported that when scanning a barcode and taking an exam, the record will be associated with a previous patient.There was no adverse event reported.This incident was captured under hillrom complaint ref # (b)(4).
Event or Problem Description
The customer reported that when scanning a barcode and taking an exam, the record will be associated with a previous patient.There was no adverse event reported.This incident was captured under hillrom complaint (b)(4).
Additional Manufacturer Narrative
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.During follow up with the customer it was confirmed that the issue had not reoccurred since the initial reported incident.A meeting was scheduled with the customer where attempts were made to recreate the reported issue but were unsuccessful.There was no problem found with the device.The situation will continue to be monitored and the customer has been asked to inform baxter if any further issues occur.Although there was no problems found with the device during testing and it was considered the incident was likely caused by use error, if the reported incident were to recur, it could lead to serious injury or death.Baxter is reporting this alleged malfunction.

• Brand Name: ELI280 AM12 AHA BAN WLAN USBD DICOM
• 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: 19959647
• Report Number: 2183461-2024-00035
• Device Sequence Number: 20599115
• Product Code: DPS
• UDI-Device Identifier: 00812345026207
• UDI-Public: 812345026207
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 09/11/2024

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-AAA-AAFBD
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/11/2024
• 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