MAUDE Adverse Event Report: MERGE HEALTHCARE, AN IBM COMPANY RADSUITE; IMAGE PROCESSING SYSTEM, PRODUCT CODE: LLZ

Model Number RADSUITE V8.30.7.9

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184); Device Operates Differently Than Expected (2913)

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

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is investigating this allegation by the customer.When additional information becomes available, a supplemental report will be submitted.

Event Description

Merge radsuite application provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.The system displays traditional 2d and reconstructed 3d radiological images using web-enabled viewers over both local and wide area networks.On (b)(6) 2016, merge healthcare support received a customer allegation indicating that they "cant invert image when using window level tool on one study".With images not being presented as expected to a user, there is a potential for a delay in treatment or diagnosis which may lead to harm.There have been no reports of delay in treatment or diagnosis to a patient or of harm as a result of this issue.(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 21jul2016.During troubleshooting efforts between the customer and merge technical support, it was found that procedures were not affected and were able to be performed and there was no delay in patient treatment.However, the captured images could not be inverted because four of the ten images were found to have a photometric interpretation of rgb (red, green, blue) and the option to invert the images in window/level appeared to be grayed out.Rgb refers to a system for representing the colors to be used on a computer display.Red, green, and blue can be combined in various proportions to obtain any color in the visible spectrum.Levels of r, g, and b can each range from 0 to 100 percent of full intensity.Device labeling, rad-100 v8.30 user manual, addresses the potential for such an occurrence in the window/level section."window/level is used to adjust the contrast and brightness of an image." a special notation states, "the application cannot set window/level on rgb images.Images from some modalities appear to be grayscale, but they are processed as rgb images." end user training of the device labeling was provided to the customer by merge technical support.No further actions are anticipated at this time due to the issue being readily apparent to the user, no delay in patient treatment occurred, and customer training was provided concerning the rgb limitations of the application.Revised information contained in this supplemental report includes the following: g4 - date new information received by manufacturer (case closure date 7/22/2016).H6 - evaluation codes: device code #1: 1184 display or visual feedback problem.Device code #2: 1181 display difficult to read.Methods code: 4112 analysis of data provided by user/third party.Results code: 213 no device problem found.Conclusions code #1: 19 cause traced to user.Conclusions code #2: 18 failure to follow instructions.H10 - indication of additional manufacturer information and corrected data are contained in this follow-up report.

• Brand Name: RADSUITE
• Type of Device: IMAGE PROCESSING SYSTEM, PRODUCT CODE: LLZ
• Manufacturer (Section D): MERGE HEALTHCARE, AN IBM COMPANY; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 5814483
• MDR Text Key: 50187877
• Report Number: 2183926-2016-00659
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K053281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RADSUITE V8.30.7.9
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1