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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 MERGE CADSTREAM V6.1.0.1010
Device Problem Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2017
Event Type  Malfunction  
Manufacturer Narrative

The issue, study reflects incorrect patient positioning on all images, was caused by incorrect data entry at the scanner. The user manual and reference guide describe the limitations of cadstream which caution diagnostic or other patient management decisions should not be based solely on the results of cadstream.

 
Event Description

Merge cadstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (mri) studies. Merge cadstream supports evaluation of dynamic mr data acquired during contrast administration. Merge cadstream performs other user selected processing functions such as image registration, subtractions, measurements, 3d renderings, and reformats. Merge cadstream also includes user-configurable features for reporting on findings in breast or general mri studies. Additionally, merge cadstream assists users in planning mri guided interventional procedures. When interpreted by a skilled physician, this device provides information that may be used for screening, diagnosis, and interventional planning. Patient management decisions should not be made based solely on the results of merge cadstream. Merge cadstream may also be used as an image viewer of multi-modality, digital images, including ultrasound and mammography. Merge cadstream is not intended for primar interpretation of digital mammography images. On (b)(4) 2017, merge support was contacted by a user at the facility for assistance with correcting the patient positioning which was entered incorrectly at the modality. Cadstream is unable to edit the original image dicom data, as such, the processed study will reflect the incorrect patient positing on all post processing images. 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. Reference complaint number (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
meg mucha
900 walnut ridge drive
hartland, WI 53029
2629123570
MDR Report Key7156138
MDR Text Key96233985
Report Number2183926-2017-00213
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK092954
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation RADIOLOGIC TECHNOLOGIST
Type of Report Initial
Report Date 12/01/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator RADIOLOGIC TECHNOLOGIST
Device MODEL NumberMERGE CADSTREAM V6.1.0.1010
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/01/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/13/2016
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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