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U.S. Department of Health and Human Services

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

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MERGE HEALTHCARE MERGE CADSTREAM IMAGE PROCESSING SYSTEM Back to Search Results
Model Number 5.2.9.2.1002
Device Problem Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/05/2017
Event Type  Malfunction  
Manufacturer Narrative

The issue, a study reflecting the incorrect patient orientation on all images, was caused by incorrect data entry, by a user, at the scanner. The merge cadstream 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

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) 2017, merge support was contacted by a user at the facility for assistance with study processing. While troubleshooting, merge support discovered the study reflected an incorrect patient orientation. The patient's orientation is entered at the scanner (modality). Cadstream does not allow for editing of this dicom information. The study was processed "as is" which lead to all images reflecting incorrect dicom on all images processed by cadstream. Due to study results having the potential to become part of the patients permanent record and records have the potential to impact a patient's treatment, 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 130128.

 
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Brand NameMERGE CADSTREAM
Type of DeviceIMAGE PROCESSING SYSTEM
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge drive
harland 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 Key6767162
MDR Text Key81919136
Report Number2183926-2017-00165
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
Type of Report Initial
Report Date 07/05/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/04/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator RADIOLOGIC TECHNOLOGIST
Device MODEL Number5.2.9.2.1002
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 Received07/05/2017
Was Device Evaluated By Manufacturer? Yes
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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