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

Model Number UNITY PACS R10.0.436.121

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Issue (2379)

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

Event Date 02/08/2017

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is continuing to investigate the issue reported by the customer.A review of the merge unity user guides did not reveal any troubleshooting or other anomalies/issues regarding database/disk array guardian issues.A review of the complaint history indicates there are three similar complaints for this issue.Trending will continue to be monitored.

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.Merge healthcare was notified by a customer on (b)(6) 2017 that all users were not able to connect to the server.Testing and investigation by merge healthcare technical support determined that the site had been experiencing ongoing storage issues with their drives.In order to resolve this hardware storage issue, merge healhcare sent the customer six (6) new one terabyte (tb) drives.The new configuration would allow for distributing the pacs storage across multiple drives ensuring that free space and regular maintenance (defragging) would occur.However, during the on-site replacement installation, the array drive in the image server failed.The failed array was replaced.In the efforts of restoring the data, four exams were unable to be recovered.Therefore, each patient had to be re-scheduled for another mammogram exam at a later date.There is a potential for patients that require re-imaging due to data loss, to experience a delay in treatment and/or diagnosis that could lead to harm.At this time, there is no indication of an adverse event for the affected patients.(b)(4).

Manufacturer Narrative

The array drive (storage device: storageworks d2600 disk enclosure) was returned to merge healthcare for further testing.Testing of the array drive found that the unit passed all integrated diagnostics, however was out of vendor warranty on 09apr2016.Therefore, the unit was scrapped.A review of complaints received from this facility found no further reports of this issue since the array drives were replaced.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).Information contained in this supplemental report includes the following:.

• 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
• MDR Report Key: 6397854
• MDR Text Key: 69843518
• Report Number: 2183926-2017-00056
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNITY PACS R10.0.436.121
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1