MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE UNITY PACS; PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM

Model Number UNITY PACS R11.0.4

Device Problems Computer Software Problem (1112); Loss of Data (2903)

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

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation into this issue is active and ongoing.Unty pacs has discovered hd archive and burn to cd are corrupting images with large look up tables (luts).In the case of hd archive, the corruption goes unnoticed until the images are restored.Some images can be restored while other images cannot be viewed (invalid image).There are exam reports available for review for all exams.Merge healthcare is further investigating the allegation from the customer to determine if any corrections or corrective actions are necessary.On may 23, 2018 the lead unity support technician contacted the designated complaint handling unit (dchu) with additional information leading dchu to submit this issue to fda.

Event Description

Merge unity pacs is 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.A unity pacs administrator reported to merge technical support on (b)(6) 2018 that an invalid image format was found on an exam that was previously read by a radiologist.Upon initial review on april 27, 2018 it was believed this issue was related to the site's supplied storage vendor.The complaint remained open for additional information but was marked as "not reportable".On may 18, 2018 new information became available.The issue with the invalid image format was determined to be unity software related.While the exam report is available, the inability to restore an exam from long term storage for viewing could potentially result in a delay in care that could lead to harm.However, the customer did not allege any harm, serious injury or death as a result of this issue.(b)(4).

Manufacturer Narrative

This issue has been identified as a software defect, resulting in corrupt data when restoring exams from long term archive.Changes were made to compression upon archive to correct this issue.Investigation determined at this time, the customer is no longer acquiring to unity pacs and has moved to another pacs system.Multiple attempts were made to contact the customer for additional information with no response.Therefore, no further investigation will be performed.This site is on time and materials.Site did not renew service contract.Per the customer: we are switching to another pacs system on monday next week.We have terminated service on this contract and all associated contracts as of march 1st, 2019.Upgrade ug-04632 request was closed per customer e-mail request on 6/4/2018.Site has declined the upgrade.Site is moving to a different pacs vendor.Attempted contact with site by both phone and e-mail multiple times.No response from customer.Contacted site field service engineer, he has had no contact with the customer.Reports they have moved to another pacs system and is no longer acquiring to unity pacs.

• Brand Name: MERGE UNITY PACS
• Type of Device: PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 7564155
• MDR Text Key: 110460772
• Report Number: 2183926-2018-00045
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K041935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNITY PACS R11.0.4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1