MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE UNITY PACS; PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM

Model Number	MERGE UNITY PACS
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Merge unity pacs is designed to display a message to the user when an exam report fails to upload to the image server.In this instance, there was no evidence that the physician received the message warning that the report did not upload.It was not possible to determine if the message displayed on the screen for the physician when the report was first read and saved.Unity investigation showed the database was updated but the report did not upload to the server.Audit trail showed the exam was read, approved and saved.Station logs had truncated, therefore were unavailable for review.Pending further review.A supplemental report will be provided.
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) 2018 the customer reported an exam was completed but there is no exam report.Unity support investigation showed the report did not upload successfully, and will have to be recreated.The audit trail does show a "report save" event.There was no reported adverse event to the patient.A missing report does have the potential to delay patient care.Reference sales force complaint-(b)(4).
Additional Manufacturer Narrative
Troubleshooting from unity support found that report failed to send due to macro and microsoft word security level.Support changed the security level for both to low.The exam was recreated and had to be re-read by the physician.Exam was reread and confirmed with customer that the report is present.Revised information contained in this supplemental report includes the following: evaluation codes: methods code: 10- testing of actual/suspected device.Results code: 104- software problem identified, 4215- data storage of loss of data.Conclusions code: 4309- cause traced to environment.

• Brand Name: MERGE UNITY PACS
• Common Device Name: PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 7728559
• Report Number: 2183926-2018-00066
• Device Sequence Number: 1107391
• Product Code: LLZ
• UDI-Device Identifier: 00842000100058
• UDI-Public: 00842000100058
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 10/12/2018

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: No Information
• Device Model Number: MERGE UNITY PACS
• Device Catalogue Number: UNITY PACS R11.1.2
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1