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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE CADSTREAM IMAGE PROCESSING SYSTEM

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MERGE HEALTHCARE CADSTREAM IMAGE PROCESSING SYSTEM Back to Search Results
Model Number 5.2.9
Device Problems Computer Operating System Problem (2898); Data Problem (3196)
Patient Problem No Patient Involvement (2645)
Event Date 11/02/2015
Event Type  malfunction  
Manufacturer Narrative
Upon retrospective review, this issue was determined to be reportable as an mdr.
 
Event Description
Cadstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (mri) studies. A customer reported (case (b)(4)) they are having issues sending images to cadstream. This could cause a delay in patient care.
 
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Brand NameCADSTREAM
Type of DeviceIMAGE 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
michael diedrick
900 walnut ridge rd
hartland, WI 53029
2629123570
MDR Report Key5437800
MDR Text Key38865560
Report Number2183926-2016-00019
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
Report Date 02/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5.2.9
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 Received11/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/23/2010
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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