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

Model Number MERGE PACS V7.0.2.1

Device Problems Improper Device Output (2953); Compatibility Problem (2960)

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

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is continuing to investigate the customer's allegation related to the 3d cad markings for measurements and calculations.When further information becomes available a supplemental report will be filed.

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 alleged an issue with a breast outline not being correct, which resulted the site to taking additional views of the patient's breast.The customer also alleged that the cad markings for measurements and calcification are incorrect on 3d images.The alleged issue with the breast outline is readily apparent to the user on mammography images.However, the issue could potentially cause a delay in diagnosis or incorrect treatment due to either additional images being taken and/or incorrect measurements.It should be noted that the customer has access to correct cad markings in 2d images and in secondary capture.At this time there is no indication of direct impact to patient care or harm as a result of this issue.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accordance with applicable regulations and as indicated by merge healthcare, an ibm company, in the initial report submitted 30june2017.After further investigation by the merge healthcare development team, it was determined that this issue is due to a defect in the code regarding how merge pacs handles the modality's graphic tag.This issue has been resolved in merge pacs version 7.1.Development also updated user documentation.This is an inconvenience to a trained user but highly detectable.Cad markings are displayed in merge pacs to bring areas of interest to the attention of the radiologist.They are intended only to assist the radiologist in minimizing observational oversights and not as a primary diagnostic tool.The underlying images are available and a trained professional can make diagnosis based on clinical knowledge.No further action needed and no patient impact.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 have a remote or greater likelihood to result in a death or a serious injury.At this time, the investigation is complete and no further actions are required.Revised information contained in this supplement report includes the following: updated manufacturer email address.Updated office contact email address.Indication that this is follow-up report 001.Indication of malfunction as reportable event.Indication that the follow-up type is additional information.Evaluation codes added: device code 2960 - compatibility problem.Method code 11 - testing of device from same lot/batch retained by manufacturer.Results code 4206 - device not compatible with another device.Conclusion code 12 - cause traced to device design.Indication that additional manufacturer information is contained in this follow-up report.

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM PACS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• MDR Report Key: 6683442
• MDR Text Key: 79246575
• Report Number: 2183926-2017-00141
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K082144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MERGE PACS V7.0.2.1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1