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

Model Number MERGE PACS 6.6.3.1

Device Problem Computer Operating System Problem (2898)

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

Event Date 11/06/2016

Event Type  malfunction  

Manufacturer Narrative

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 three dimensional 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 that when a user exits out of study in fluency, merge pacs changes the status of the study to "read." when a study unexpectedly goes to a read status when exiting out of that study, there is a potential for delay in diagnosis due to a customer missing reading the study.However, this issue was detected by the customer and there was no reported impact to patient care.(b)(4).

Manufacturer Narrative

After further investigation, tt was found fluency is not using a standard integration point.This changed when they started integrating with mrs and communicating results to them and a custom integration point was created.Fluency made changes to status.Xml logic to match that of the standard integration point.Support confirmed merge pacs is working as expected with the standard integration point in fluency.The customer confirmed fluency resolved the issue.

• 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: 6150225
• MDR Text Key: 61886083
• Report Number: 2183926-2016-00815
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE PACS 6.6.3.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2016
• 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