MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number 6.3

Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)

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

Event Date 08/03/2014

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be reportable.

Event Description

Merge pacs (picture archiving communication system) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.A customer reported (case (b)(4)) that unviewed images were not displaying after the last hanging protocol step.When the user preference "show unviewed images after the last hanging protocol step" is selected, the customer expects that any images not matched to the hanging protocol will display in an auto-generated final view.However, if the last defined view of the protocol was skipped (because no images matched), the unviewed images are not displayed.This was determined to be a potential safety issue because of the risk associated with not viewing all of the images in the study.

Manufacturer Narrative

Submitting this supplemental report to add fda correction and removal reference numbers.

• Brand Name: MERGE PACS
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• 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 dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437916
• MDR Text Key: 38857776
• Report Number: 2183926-2015-00135
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K082144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/15/2016

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: No Information
• Device Model Number: 6.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2014
• Initial Date FDA Received: 02/16/2016
• Supplement Dates Manufacturer Received: 08/03/2014
• Supplement Dates FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0599-2017; RES 75629
• Patient Sequence Number: 1