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

Model Number	MERGE UNITY PACS R11.0.0
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2018
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.
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 a customer reported to merge unity technical support than an exam report was missing.The merge unity support technologist's investigation into the customer's allegation showed that the report did not upload successfully, and would have to be recreated.The audit trail does show a "report save" event.While images are available, a finalized report not being available for subsequent review by the patient's physician could potentially result in a delay in care that could lead to harm.However, the customer did not allege any harm, serious injury or death as a result of this issue.(b)(4).
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.The audit trail showed the exam was read, approved and saved.After unity support provided the user with a new template, the doctor was able to re-read the exam and complete the report.The pacs admin was able to confirm that the issue was resolved.No patient impact reported.Revised information contained in this supplemental report includes the following: methods code: 22 - software evaluation (blank in initial report).Results code: 104 - software problem.Conclusions code: 17 - evaluation conclusion.

• 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: 7524223
• Report Number: 2183926-2018-00040
• Device Sequence Number: 1425124
• Product Code: LLZ
• UDI-Device Identifier: 00842000100058
• UDI-Public: 00842000100058
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K041935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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: Health Professional
• Device Model Number: MERGE UNITY PACS R11.0.0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1