MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE UNITY PACS; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ

Model Number	UNITY PACS 12.0.4
Medical Device Problem Codes	Computer Software Problem (1112); Loss of Data (2903)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Merge unity pacs is a medical image and information management system that is used for viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.On (b)(6) 2020, the customer reported receiving an exam report with no report body to (b)(6) health imaging on the same day.Troubleshooting from (b)(6) health imaging support found that there were no patient demographics, body, or conclusion data included in the report file.There was a report save event in the audit trail.Using the revision button from the dictation dialog box, the report template was re-generated and the report was then viewable as expected.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).
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 05/12/2020.Upon research of the initial issue, it was discovered that the product version was unity pacs 12.0.4.No patient harm is associated with this report and no further action is required.Revised information contained in this supplemental report includes the following: d4.Model number.

• Brand Name: MERGE UNITY PACS
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland, wi
• MDR Report Key: 10227697
• Report Number: 2183926-2020-00021
• Device Sequence Number: 10911256
• Product Code: LLZ
• UDI-Device Identifier: 00842000100744
• UDI-Public: 00842000100744
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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: UNITY PACS 12.0.4
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 07/05/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1