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

Model Number MERGE UNITY PACS R11.1.2.5

Device Problem Loss of Data (2903)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2019

Event Type  malfunction  

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.Troubleshooting from unity support found that there was a reported generated, however the document was not associated correctly to the exam.The exam was generated again by the site and the they confirmed that the exam was able to be re-read without incident.No further action required at this time.

Event 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) 2019 the customer reported an exam was marked read, however, there is no exam report.The report was saved, but not associated properly with the exam.A cause of the failed association was not able to be determined.An investigation showed the report did not upload successfully and had to be read again by the doctor.There was no reported adverse event to the patient.However, 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.Reference complaint (b)(4).

• Brand Name: MERGE UNITY PACS
• Type of Device: PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: meg mucha ; 900 walnut ridge drive; hartland, WI 53029
• MDR Report Key: 8432018
• MDR Text Key: 139841160
• Report Number: 2183926-2019-00008
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00842000100058
• UDI-Public: 00842000100058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE UNITY PACS R11.1.2.5
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1