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

Model Number MERGE PACS V6.4.3

Device Problems Use of Device Problem (1670); Data Back-Up Problem (2902)

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

Event Date 05/09/2017

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is continuing their investigation and will determine if any further actions are required.

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 and marketed for soft copy reading, communication, and storage of studies produced by digital modalities.On (b)(6) 2017, a customer reported the number of images on their local mammo servers do not match the number of images on their pacs server.There is a potential risk of the customer removing images from the mammo server under the assumption that the images have been archived properly to the pacs server.At this time, all images are being transferred to the server and there is no evidence of loss of data/images.However, the issue could potentially cause a delay or incorrect treatment due to a physician not being able to view a patient's prior studies for comparison with the current study.(b)(4).

Manufacturer Narrative

Supplemental report conclusions: after further investigation by merge healthcare technical support, it was determined that the customer is currently storing mammo images on an unsupported version of merge pacs.By using an unsupported version, the larger images are not storing to the mammo server.The customer has read the images and reports are available to physicians for comparison purooses.The primary image is the basis for treatment and diagnosis as it contains the most recent images.Any prior images that were evaluated in the past are used as aids only for comparison or historical purposes.Merge healthcare is not solely responsible for the customer's environment.Customers are responsible for ensuring that their systems can manage and store expected studies.The customer understands the risks of storing larger than expected images on their unsupported version.In order to service the customer's needs, technical support has developed a script to run for the customer to assist the pacs administrator and users in checking for any missing images on the mammo server.Based on the results of merge healthcare's investigation, the customer's complaint does not meet the requirements for medical device reporting.The customer's issue did not result in harm nor would a recurrence be likely to result in harm.

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM PACS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland, wi 53029, WI 53029
• Manufacturer Contact: mike diedrick ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 6624200
• MDR Text Key: 77319698
• Report Number: 2183926-2017-00117
• 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
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MERGE PACS V6.4.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2012
• 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