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

Model Number	UNITY PACS 11.1.2.7
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	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history logs found no errors indicating the failure of the reports to upload, however it was noted that universal manager (um) crashed.Troubleshooting from unity support found the exams in the failed results out queue.The exams were all read and approved in approved (apd) status with report id's.The reports folder was manually checked, however, none of the reports had report folders.The report statuses were updated to dictated (did) and resent to the user re-dictation.Unity support confirmed that all five reports were re-read successfully.No further investigation will be performed.
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.The customer contact reported on (b)(6) 2019 there were five exams with corrupted reports from (b)(6) 2019 from two different reading stations.There was no reported adverse event to the patient.However, while images were available, a corrupted report could potentially result in a delay in care that could lead to harm.Reference complaint (b)(4).

• Brand Name: MERGE UNITY PACS
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 8911821
• Report Number: 2183926-2019-00026
• Device Sequence Number: 11219724
• Product Code: LLZ
• UDI-Device Identifier: 00842000100058
• UDI-Public: 00842000100058
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/26/2019

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 11.1.2.7
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1