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

Model Number	UNITY PACS 11.0.6
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	06/24/2020
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 a "no object found" error when trying to open a report for dictation to ibm watson health imaging on (b)(6) 2020.Troubleshooting from ibm watson health imaging support found that the report folder was empty, causing the "no object found" error, and that there was a report save event present in the device audit trail.Ibm watson health imaging support regenerated the report template and saved it in dictated (did) status.The report was saved with the new template.The report was then readable.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 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: 10192498
• Report Number: 2183926-2020-00022
• Device Sequence Number: 14129890
• Product Code: LLZ
• UDI-Device Identifier: 00842000100461
• UDI-Public: 00842000100461
• 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
• Report Date (Section B): 06/24/2020

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 11.0.6
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1