MAUDE Adverse Event Report: MERGE PACS; PICTURE ARCHIVING COMMUNICATION SYSTEM PACS

Model Number	MERGE PACS 8.0.2
Medical Device Problem Code	Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Merge pacs is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings.Merge pacs processes and displays medical images from dicom-compliant modalities.The device is designed to enable efficient workflows by maintaining clinicians' worklists and retrieving and managing studies for reading, reporting, communication, and storage.Merge pacs software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (vnas) such as iconnect enterprise archive (icea) for image storage, and with radiological and hospital information systems (ris and his) and medical record systems (emr, ehr, etc.).Merge pacs can be accessed from within the hospital or enterprise, or from remote locations via web-based access.Images viewed on mobile devices must not be used for diagnostic review.On (b)(6) 2021, a customer contacted merge healthcare to report that there were discrepant roi (region of interest) values between 2d and mpr images.Merge healthcare support worked with the customer to reproduce the issue.The issue is confined to the 3d flair series of images only.This issue has been corrected in the current release of merge pacs and the customer was informed of this.No further action is necessary at this time.This has the potential to delay patient treatment and/or diagnosis.There have been no reports of patient injury or harm as a result of this issue.Reference complaint (b)(4).

• Brand Name: MERGE PACS
• Common Device Name: PICTURE ARCHIVING COMMUNICATION SYSTEM PACS
• MDR Report Key: 11996143
• Report Number: 2183926-2021-00013
• Device Sequence Number: 19063421
• Product Code: LLZ
• UDI-Device Identifier: 00842000100737
• UDI-Public: (01)00842000100737(10)8.0.2.166115(11)190708
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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: MERGE PACS 8.0.2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2019
• 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