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

Model Number MERGE UNITY PACS V11.0.403.0

Device Problems Computer Software Problem (1112); Device Issue (2379)

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

Event Date 02/21/2016

Event Type  malfunction  

Manufacturer Narrative

Based on the investigation into the database and scheduled system maintenance at the site, the database was shut down a few hours prior to the scheduled shut down.This was not something that merge healthcare had any control over.The device was operating as expected and as intended until the power was unexpectedly shut down.This is likely the result of a user error.

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 by a pacs administrator that server maintenance had been performed and the site was not able to restart the database.Merge healthcare worked with the customer to further investigate the issue.It has been determined that prior to the scheduled server maintenance, the database was unexpectedly powered down while tasks were still pending.This unexpected shutdown resulted some lost data.Merge healthcare assisted the site and utilizing backups and other restoration procedures the database was able to be restored and was functional prior to the next business day.The primary impact to the clinical workflow was a radiologist needing to re-read about 70 exams.There are 4 remaining reports that merge is assisting the site with reconstructing.The inability to view reports and images may result in a potential to delay in treatment and/or diagnosis a patient.The customer did not indicate any harm to patients whose data may have been impacted by the unexpected shutdown of the database.(b)(4).

• Brand Name: MERGE UNITY PACS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• 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: 5518883
• MDR Text Key: 40937485
• Report Number: 2183926-2016-00502
• 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
• Type of Report: Initial
• Report Date: 02/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: MERGE UNITY PACS V11.0.403.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2016
• Initial Date FDA Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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