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

Model Number 11.2.1

Device Problem Unintended Application Program Shut Down (4032)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

Event Type  malfunction  

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.On (b)(6) 2020, a customer contacted merge healthcare to inform us that their merge unity pacs system was completely down.Troubleshooting and technical support is ongoing between merge healthcare and the customer.When more information becomes available, a supplemental report will be filed.This has the potential to delay patient treatment and/or diagnosis.There have been no reports of patient injury or harm as a result of this issue.Reference complaint (b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted 1/28/2021.After additional troubleshooting by merge healthcare technical support, it was determined that the virtual machine (vm) snapshots were enabled on (b)(6) 2020, which slowly filled up the vm stores.The vm ran out of storage, therefore, the system halted.The snapshots were removed and space returned, but disk check procedures took multiple hours.It was also determined that the site doesn't regularly maintain/clean-up their in-progress exams.The site was counseled regarding storage space maintenance.No further action is required.Revised information contained in this supplemental report includes the following: g3 - date new information received by manufacturer g6 - indication that this is follow-up report 001 h1 - indication of malfunction as reportable event h2 - indication of additional information h3 - indication that device evaluated by manufacturer h6 - evaluation codes: investigation findings 4215 data storage or loss of data investigation conclusions: 4309 cause traced to environment there were no reports of death, serious injury or injuries that were directly caused or contributed to as a result of this issue.

• Brand Name: MERGE UNITY PACS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• MDR Report Key: 11244754
• MDR Text Key: 257205200
• Report Number: 2183926-2021-00003
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 008420001000331
• UDI-Public: (01)008420001000331(10)11.2.1.15942(11)180627
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11.2.1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2018
• 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