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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 CADSTREAM V5.2.9.711
Device Problem Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/02/2017
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

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. On (b)(6) 2017, merge support was contacted by a user at a 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 positiong on all post processing images. 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. (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 dr
harland WI 53029
Manufacturer Contact
meg mucha
900 walnut ridge dr.
hartland, WI 53029
2629123570
MDR Report Key6832398
MDR Text Key84126377
Report Number2183926-2017-00173
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 USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 08/02/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/30/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator RADIOLOGIC TECHNOLOGIST
Device MODEL NumberCADSTREAM V5.2.9.711
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/02/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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