MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE ICONNECT ENTERPIRSE ARCHIVE; DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM

Model Number MERGE ICEA V10.0.2

Device Problem Image Display Error/Artifact (1304)

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

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

An initial investigation has determined that this issue is occurring due to the way ea stored some of the customer's images.When trying to open the images in pacs, they were "black" and not viewable.The merge ea (enterprise archive) morpher that was in place essentially altered dicom tags for various reasons.Merge healthcare support is working with the customer to change the morpher to ensure that tomography images are stored and can be retrieved without appearing as black.

Event Description

Merge iconnect enterprise archive (icea) consolidates, standardizes and archives dicom and non-dicom images and data from disparate pacs, specialties and sites.Icea works with merge pacs which 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 marked for soft copy reading, communication and storage of studies produced by digital modalities.On (b)(6) 2016 a customer reported to merge healthcare support that "tomo studies retrieved from the ea (enterprise archive) into merge pacs are viewing as black." an investigation determined that the tomography images retrieved in pacs are displaying "black" because the site was using customer managed morphers that was handling pixel data values differently than expected.Due to the images being "black" and not viewable, there is a potential for a delay in patient treatment or diagnosis or patient harm.However, there were no reports of delays in patient treatment or diagnosis.There were no reports of patient harm.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted 10/09/2016.Merge healthcare conducted an internal investigation ((b)(4)) to address the customer's reported issue.During troubleshooting efforts between the customer and merge technical support, it was found that this issue was caused from the site using a customer-managed morpher that used a tag beyond the acceptable pixel data tag causing the images to display black.Morphers are small software modules that alter dicom (digital imaging and communications in medicine) image attributes that follow other standards using morphing actions when certain matching conditions are met.In this instance, the issue occurred due to the way ea (enterprise archive) stored the images with the customer-managed morpher causing the images to display black when they were opened in pacs.Due to the images being black and not viewable there was a potential for delay in treatment; however there were no reports of delay in treatment and/or diagnosis.Additionally, pacs technical support successfully retrieved most of the images from archive.Although there were a few studies that had no salvageable images, the original reports were available for viewing (reference complaint-(b)(4)).Merge technical support worked with the customer to change the morpher to trigger based upon the source ae (archive explorer) such as the existence of a patient id rather than a port number (communication mode to another device).No further actions are anticipated at this time due to the issue being readily apparent to the user, changing the morpher for better compatibility, successful retrieval of the images from archive, and no known impact to the patient.Revised information contained in this supplemental report includes the following: g4 - date new information received by manufacturer (change request updated 3/31/2017).H4 - added device manufacture date (7/21/2015).H6 - evaluation codes: methods code: 4112 analysis of data provided by user/third party.Results code #1: 104 software problem identified.Results code #2: 4214 erroneous data transfer.Conclusions code #1: 12 cause traced to device design.Conclusions code #2: 4302 human factors engineering - device difficult to operate.H10 - indication of additional manufacturer information and corrected data are contained in this follow-up report.

• Brand Name: MERGE ICONNECT ENTERPIRSE ARCHIVE
• Type of Device: DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 6012991
• MDR Text Key: 56978438
• Report Number: 2183926-2016-00752
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• PMA/PMN Number: K05328124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/07/2016

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 ICEA V10.0.2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/07/2016
• Initial Date FDA Received: 10/09/2016
• Supplement Dates Manufacturer Received: 03/31/2017
• Supplement Dates FDA Received: 10/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1