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

Model Number	UNITY PACS R11.1.2.5
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2018
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, who was reviewing the exams from a home computer, 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.The merge healthcare unity investigation allowed the recovery of two of the reports.The cause of the other four reports failing to load was due to the physician's home workstation crashing during the upload of the six reports.This caused four of the six report documents to be lost.To resolve this issue, the other 4 exams were re-read by the physician.No other review/investigation will be performed for cause.
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 there were no reports for 6 mammography exams.The reports were read by one physician on a home reading station in one session.The merge healthcare unity support technician investigated the exams, and all of them did have report ids with folders in i:\reports.Two of the six exam reports were recovered, the other 4 exams were re-read by the physician.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).

• 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: 8124285
• Report Number: 2183926-2018-00097
• Device Sequence Number: 16574627
• Product Code: LLZ
• UDI-Device Identifier: 00842000100058
• UDI-Public: 00842000100058
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/12/2018

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: Health Professional
• Device Model Number: UNITY PACS R11.1.2.5
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1