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

Model Number	9.2.1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Merge healthcare is submitting this report to us fda due to an issue with a third-party application used for reporting and dictation that led to a potential patient safety risk.The third-party application interoperates with the company's merge pacs and merge workflow orchestrator products.Neither the third-party application nor merge workflow orchestrator are regulated as medical devices.A customer contacted merge healthcare technical support on (b)(6)2025 to report that a patient's imaging study had been read incorrectly by a radiologist.The customer alleged that merge pacs and the dictation system displayed images for the incorrect patient.As a result, a patient was sent offsite for further treatment.No patient harm occurred, as hospital staff identified that the clinical history in the report did not match the order requisition for the patient.Merge healthcare initiated an investigation with the third-party vendor for the dictation system.Based on an analysis of the system log files, it was determined that the user had opened two patient exams in quick succession.The results of the investigation concluded that the correct images for the patient were displayed by merge pacs.However, the third-party application displayed the incorrect patient report due to a timing issue when processing multiple, rapid user interactions.It has been determined that the root cause of the reported event is due to a software issue in the third-party application; the vendor has issued a software update to prevent the problem from reoccurring and is deploying the update to affected customers.Merge pacs and merge workflow orchestrator are working as designed.Merge healthcare is reporting this event due to the incident communicated by the customer.To merge healthcare's knowledge, there have been no other instances of this issue occurring.

• Brand Name: MERGE PACS
• Common Device Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge 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: 21671425
• Report Number: 2183926-2025-00015
• Device Sequence Number: 12792222
• Product Code: LLZ
• UDI-Device Identifier: 00842000101154
• UDI-Public: (01)00842000101154(10)9.2.1(11)240807
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192455
• 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): 03/21/2025

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
• Device Model Number: 9.2.1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 03/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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: Other
• Patient Sex: Unknown