MAUDE Adverse Event Report: MERGE CADSTREAM; IMAGING PROCESSING SYSTEM

Model Number	6.2.2.1184
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Event or Problem 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) 2021, 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.Merge healthcare currently has a request for cessation of reporting filed with the agency concerning this issue.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
• Common Device Name: IMAGING PROCESSING SYSTEM
• MDR Report Key: 11448468
• Report Number: 2183926-2021-00006
• Device Sequence Number: 3359290
• Product Code: LLZ
• UDI-Device Identifier: 00842000100638
• UDI-Public: (01)00842000100638(10)6201096(11)170530
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K092954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: 6.2.2.1184
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 03/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1