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U.S. Department of Health and Human Services

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

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MERGE HEALTHCARE MERGE CADSTREAM IMAGING PROCESSING SYSTEM Back to Search Results
Model Number 6.2.2.1184
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
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 7/12/2021, a customer contacted merge healthcare to request assistance with re-prcessing 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).
 
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Brand NameMERGE CADSTREAM
Type of DeviceIMAGING PROCESSING SYSTEM
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
brian bell
75 binney street
cambridge, MA 02142-1123
3123540189
MDR Report Key12271516
MDR Text Key265185891
Report Number2183926-2021-00019
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092954
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6.2.2.1184
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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