MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE CADSTREAM; IMAGING PROCESSING SYSTEM

Model Number 6.0.1.933

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  malfunction  

Event Description

Cadstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (mri) studies.Cadstream supports evaluation of dynamic mr data acquired during contrast administration.Cadstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3d renderings, and reformats).On (b)(6) 2020, a customer contacted merge healthcare to request assistance with re-processing images that were believed to be processed incorrectly.Support reviewed the incoming images and system remotely.Support found that the images appeared to be scanned with incorrect patient orientation.The customer confirmed the orientation of the images.Cadstream does not allow for the editing or modification of the original image.The customer has the ability to make annotations regarding the orientation, however, cadstream will continue to reflect the orientation as originally scanned on the processed images.Support instructed the customer regarding these images and orientation.The incorrect orientation is not a malfunction of the cadstream device nor is it a failure of the device to meet specification.The issue is use error caused originating at the mri scanner due to improper data entry.This has the potential to delay patient treatment and/or diagnosis.There have been no reports of patient injury or harm as a result of this issue.Reference complaint (b)(4).

• Brand Name: MERGE CADSTREAM
• Type of Device: IMAGING PROCESSING SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 10718937
• MDR Text Key: 212558927
• Report Number: 2183926-2020-00043
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K092954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6.0.1.933
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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