MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE UNITY PACS; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ

Model Number UNITY PACS R11.0.455.12641

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Seizures (2063)

Event Date 11/15/2016

Event Type  Death  

Manufacturer Narrative

A review of the complaint history found no occurrences related to the reported event that could cause or contribute to the reported event.Merge will continue to monitor complaints for this issue.Should new information become available, a supplemental report will be provided.Based on the information provided by the customer, the cause of this event is most likely not related to a merge product and appears to be the result of a patient not adhering to a clinician's instructions.

Event Description

Merge unity pacs a medical image and information management system that is used for viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.On (b)(6) 2016, merge was notified that a patient death occurred.The notification was provided via email while inquiring about whether there is a notification or warning for an exam when a technologist does not review all images.On (b)(6) 2016, follow up calls were made to the customer in order to gather additional information.The facility provided further information regarding the incident.The patient was seen on a friday afternoon and images were obtained.After the images were captured, the patient was instructed that they were not to operate a motor vehicle based on a known seizure issue.The facility further clarified that they have no malfunction to report regarding merge healthcare products.The e-mail from the customer appears to have only been an inquiry so that the customer could further review their workflow of scanning patients.(b)(4).

Manufacturer Narrative

The initial report that was submitted for 2183926-2016-00797 was erroneously submitted as a 5 day report.This was an error as merge healthcare was not required to initiate any actions to prevent an unreasonable risk of substantial harm.The report should have been submitted as a 30 day report.

• Brand Name: MERGE UNITY PACS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; 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: 6115829
• MDR Text Key: 60411642
• Report Number: 2183926-2016-00797
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNITY PACS R11.0.455.12641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2016
• 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
• Patient Outcome(s): Death