MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS; PICTURE ARCHIVING COMMUNICATION SYSTEM (PACS), PRODUCT CODE: LLZ

Model Number MERGE PACS 6.6.2.2

Device Problem Computer Software Problem (1112)

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

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

The customer had requested that global patient update be switched back to the default setting off.After this configuration change was made the site restarted services to make sure changes took effect.No further action is 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 the customer reported that they were experiencing an issue with merging patient demographics.It was found that the global patient update was turned on during implementation at the customer site and would update or merge all patients associated with a single mrn/ipid.Which resulted in patient information to be updated to the incorrect patient in their system when duplicate mrn numbers occur.This issue has a potential to lead to patient information being compromised or overwritten by a new study submission.There was no indication from the customer that there were any patients who were harmed as a result of this issue.Additionally, if global patient update was set to off, patients with the same mrn numbers would not be merged.Reference complaint number (b)(4).

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM (PACS), PRODUCT CODE: LLZ
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge; 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: 6111879
• MDR Text Key: 60295523
• Report Number: 2183926-2016-00792
• 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: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE PACS 6.6.2.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2015
• 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