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

Model Number	12.3.2
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation into the reported issue is ongoing.A supplemental report will be filed when additional information becomes available.
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 (b)(6) 2025, merge healthcare received a complaint from a customer alleging that derived measurements were not updating after a second study report was sent to merge cardio with some updated measurements.Merge healthcare is investigating the root cause and there have been no reports of patient injury or harm because of this issue.
Additional Manufacturer Narrative
This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted 02/07/2025.An investigation by merge healthcare has identified a potential issue when using merge cardio that may affect the display of calculated measurements in a final patient report.Under certain circumstances, when primitive measurements are updated for echocardiography (echo) or vascular ultrasound exams, the associated calculated (derived) measurements may not be properly updated in the final report.When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in clinical reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.If this issue occurs, there is a possibility that a physician may incorrectly diagnose and treat a patient's condition.As of the date of this notice, there have been no reports of serious illness or death related to this issue.Merge healthcare has developed a configuration update to alert users to only perform changes using the measurement tools available within image review.The configuration update has been implemented on the complainant's system.Merge healthcare is developing a software update for future versions of merge cardio to prevent this issue from occurring.Revised information contained in this supplemental report includes the following: g6 - indication that this is follow-up report 001.H1 - indication of malfunction as reportable event.H2 - indication of additional information and correction.H6 - evaluation codes: investigation findings (c): remove 3233, added 3239 and 4248.Investigation conclusions (d): remove 11, added 61, 4305 and 4318.

• Brand Name: MERGE CARDIO
• Common Device Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer Contact: nadia marchant ; 900 walnut ridge dr; hartland, WI 53029 ; 8446372848
• MDR Report Key: 21334896
• Report Number: 2183926-2025-00013
• Device Sequence Number: 3826109
• Product Code: LLZ
• UDI-Device Identifier: 00842000101109
• UDI-Public: (01)00842000101109(10)12.3.2(11)230612
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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
• Operator of Device: Health Professional
• Device Model Number: 12.3.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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