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

Model Number MERGE PACS 8.0.2

Device Problem Application Program Problem: Parameter Calculation Error (1449)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2021

Event Type  malfunction  

Event 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
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM PACS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 11996143
• MDR Text Key: 258125832
• Report Number: 2183926-2021-00013
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00842000100737
• UDI-Public: (01)00842000100737(10)8.0.2.166115(11)190708
• Combination Product (y/n): N
• PMA/PMN Number: K192455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE PACS 8.0.2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1