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

Model Number MERGE PACS

Device Problems Computer Software Problem (1112); Problem with Software Installation (3013)

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

Event Type  malfunction  

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)(4) 2016, merge healthcare was notified by a customer that when additional images are sent to a study that has already been read, there was no notification that additional studies had been received.The status remains as "read" or "final status" rather than indicating "unverified new image" has been received via an alert notification.It is unknown to the customer when the problem for the alert not being received first occurred.Currently, there is no known impact to specific or overall patients; however, there is potential for a situation to occur where new images are not read resulting in delayed or incorrect treatment.The customer will be modifying a configurable software setting within the merge pacs device to evaluate if the alert is received for studies that have been read but additional images are sent for the study.

Manufacturer Narrative

The customer decided to change their overwrite setting to "yes" which will flip the status of the study when new images are received.After testing in their test environment, the customer confirmed they implemented this change in production.Merge took further action to update the merge pacs upgrade and install instructions to remove any modifications of the overwrite status to ensure the setting remains the same as previously configured.If the customer chooses, they may have this setting turned on and off as needed.No further corrective actions will be taken at this time.

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM (PACS)
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• MDR Report Key: 5456699
• MDR Text Key: 38886555
• Report Number: 2183926-2016-00457
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K082144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE PACS
• Device Catalogue Number: 6.6.2.2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1