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

Model Number MERGE PACS V7.1

Device Problem Human Factors Issue (2948)

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

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

After further investigation, merge support found each study went to read status due to the customer's configuration settings with the routing rules going to the archive server.The studies would route to the archive server before routing to production which triggered the study to flip statuses based on rules in place for the archive server.The customer resolved this issue by adding a 2 minute delay to the routing rule.No malfunction of merge product was found.No further actions needed at this time.

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) 2018, a customer stated merge pacs changed the study status to read, which made it unavailable on the worklist.When a study automatically goes to read, there is a potential for delay in the diagnosis because the customer could miss reading the study in a timely manner.However, for this customer, the event was detected by the physician and there wasn't any impact to patient care.Other clinical data was available to support the proper treatment of the patient.Reference (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: meg mucha ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123514
• MDR Report Key: 7321334
• MDR Text Key: 101986057
• Report Number: 2183926-2018-00016
• 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
• Report Date: 02/07/2018

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
• Device Operator: Other
• Device Model Number: MERGE PACS V7.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2016
• 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