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U.S. Department of Health and Human Services

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

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MERGE CADSTREAM MERGE CADSTREAM IMAGING PROCESSING SYSTEM Back to Search Results
Model Number CADSTREAM V5.2.9.1002
Device Problem Improper or Incorrect Procedure or Method
Event Date 10/26/2018
Event Type  Malfunction  
Manufacturer Narrative

The issue, study reflects incorrect patient orientation on all images, was caused by incorrect data entry at the mr scanner. This is not an issue or malfunction that was caused or contributed to by the merge cadstream medical device. Cause due to an error by a technician at the scanner. No know impact to patient. No further actions are anticipated at this time.

 
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) 2018, merge technical support was contacted by a user at the facility for assistance processing a study with incorrect patient laterality, which was entered incorrectly at the mr scanner. The customer was advised the patient laterality could not be corrected in cadstream. Cadstream is prohibited from editing or modifying image dicom data, including patient orientation and laterality, received from other application entities. Study results having the potential to become part of the patients permanent record and records have the potential to impact a patient's treatment, therefore there is a possibility for a misdiagnosis or mistreatment that could lead to harm. There is no indication that this issue as reported by the customer has resulted in any harm to a patient. (b)(4).

 
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Brand NameMERGE CADSTREAM
Type of DeviceIMAGING PROCESSING SYSTEM
Manufacturer (Section D)
MERGE CADSTREAM
900 walnut ridge drive
hartland WI 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer Contact
meg mucha
900 walnut ridge drive
hartland , WI 53029
2629123570
MDR Report Key8098027
Report Number2183926-2018-00093
Device Sequence Number1
Product CodeLLZ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/21/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCADSTREAM V5.2.9.1002
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/14/2012
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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