MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS; PICTURE ARCHIVING COMMUNICATION SYSTEM PACS

Model Number MERGE PACS 7.0.2

Device Problem Programming Issue (3014)

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

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

Upon investigation, merge support found the customer had the "com.Amicas.Util.Status.Overwritefuturestatus" setting set to "no" when they upgraded to merge pacs software from version 6.0 mr4 cu3 to version 7.0.2.The customer was unaware this setting changed during their upgrade.The customer did test the new merge pacs software in their test environment for many months before they went live to full production in august 2016.The customer confirmed they understood the risks of the setting and wanted to keep this status set to "no".The customer currently notifies the radiologists when additional images are sent.At this time, merge healthcare is continuing their investigation and will determine if any further actions are required.

Event Description

Merge pacs is a picture archiving communication system that is intended to create and display two-dimensional and threedimensional images of anatomy from a series of digitally acquired images.Pacs is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities.On (b)(6) 2016, a customer reported in their previous merge pacs version that if a document or image was added to a study after it was marked "read", it would change the status back to "unverified".After their upgrade, they noticed the study status was not changing when additional documentation was added.With a customer being potentially unaware when a new image is added to a study, there is a potential for delay in the diagnosis and/or treatment of a patient that could lead to harm.However, the issue was apparent to the user and there is no indication of harm to a patient.(b)(4).

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM PACS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland, wi 53029, WI 53029
• Manufacturer Contact: mike diedrick ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5992785
• MDR Text Key: 56806505
• Report Number: 2183926-2016-00751
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE PACS 7.0.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2014
• 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