MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS; PICTURE ARCHIVING COMMUNICATION SYSTEM (PACS)

Model Number MERGE PACS V6.6.2

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

Patient Problem Missing Value Reason (3192)

Event Date 03/07/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Customer reported on (b)(6) 2016 enterprise wide slowness.A reorganization of the customer's dicom tables was needed.This started on (b)(4) 2016 and was completed approx.8 hours later.

Event Description

Merge pacs is a picture archiving communication system that is intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.Pacs is designed for soft copy reading, communication, and storage of studies produced by digital modalities.A customer reported on (b)(6) 2016 that they were experiencing enterprise wide slowness.They were having issues pulling orders from the worklist.Merge pacs was slow to scan, send and retrieve and the customer stated they were not able to burn a cd due to these issues.Merge support began investigating the issue and found a related support case (b)(6).That case had been opened on (b)(6) and another member of the support team was already working with site on slowness issues.This case was closed as a duplicate and information was transferred to original case.This report is being issued as a result of the customer reporting again issues with slowness prior to the dicom tables were being reorganized.The slowness has a potential of leading to a delay in a treatment of diagnosis of a patient.(b)(4).

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM (PACS)
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer Contact: mike diedrek ; 900 walnut ridge dr; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5543368
• MDR Text Key: 41720503
• Report Number: 2183926-2016-00525
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/07/2016

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: Health Professional
• Device Model Number: MERGE PACS V6.6.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 04/02/2016
• 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