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

Model Number UNITY PACS R10.0.436.121

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Issue (2379)

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

Event Date 02/08/2017

Event Type  malfunction  

Manufacturer Narrative

Further testing and investigation by merge support found that launching the publishing communicator application was triggering some event causing the main pacs database to go offline.The drive was re-enabled, re-shared, and the image server was rebooted.At this time it appears that the customer's issue has been resolved and no further corrections are required.A review of the merge unity user guides did not reveal any troubleshooting or other anomalies/issues regarding database/disk array guardian issues.A review of the complaint history indicates there is no significant trend.Trending will continue to be monitored.

Event Description

Merge unity pacs 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.Merge healthcare was notified by a customer on 02/08/2017 that all users were not able to connect to the server.Testing and investigation by merge technical support found that whenever the communicator connected to the database, the database went down.To assist in correcting this issue, technical support rebuilt the database.As a consequence of having to rebuild the database, eight (8) exams reverted back to "scanned" status.These exams then needed to be re-read.There was no reported adverse event to a patient.However, exams needing to be resent and re-read has the potential to delay patient treatment and/or diagnosis.(b)(4).

• Brand Name: MERGE UNITY PACS
• Type of Device: PICTURE ARCHIVING AND 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: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 6397855
• MDR Text Key: 69821560
• Report Number: 2183926-2017-00054
• Device Sequence Number: 1
• Product Code: LLZ
• 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: Other
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNITY PACS R10.0.436.121
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2015
• 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