MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE CARDIO; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number	12.1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Heart Problem (4454); Insufficient Information (4580)
Date of Event	02/08/2025
Type of Reportable Event	Death
Event or Problem Description
Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from merge healthcare and other vendors systems including images, hemodynamic studies and reports, measurements (via import from dicom structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.Merge cardio is intended to allow users to review diagnostic and non-diagnostic quality images, annotate studies, perform digital subtraction on images, to perform quantitative measurements on images (including but not limited to quantitative coronary analysis, left ventricular analysis, time, area, length, velocity, angle, volume, and velocity-time integrals), to generate physician generated clinical reports (via structure reporting and template based tools), and to store this information in a database.On 02/19/2025, a customer contacted merge healthcare for assistance with merge cardio's study list filters.Merge technical support remotely connected to the customer's system to assist with filter questions.The customer was attempting to locate a echocardiogram patient study performed on (b)(6) 2025 and was unable to create a new filter to locate the imaging study.Technical support provided assistance to enable the customer to create the study list filter.Merge technical support assisted the customer with finding the study and confirmed that the new study list filter worked as expected.The customer representative mentioned to technical support that the patient had passed away on (b)(6) 2025.Merge healthcare followed up with the customer to gather more information and determined that the patient outcome was due to a preexisting condition.Based on the available information, merge cardio is performing as designed and did not cause or contribute to the patient outcome.If new information becomes available, a supplemental report will be submitted.

• Brand Name: MERGE CARDIO
• Common Device Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut creek drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: nadia marchant ; 900 walnut ridge drive; hartland, WI 53029 ; 8446372848
• MDR Report Key: 21656629
• Report Number: 2183926-2025-00014
• Device Sequence Number: 7498925
• Product Code: LLZ
• UDI-Device Identifier: 00842000100928
• UDI-Public: (01)00842000100928(10)12.1(11)210122
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K192276
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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
• Operator of Device: Health Professional
• Device Model Number: 12.1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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: Death
• Patient Sex: Unknown