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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 V6.2.2.1184
Device Problem Improper or Incorrect Procedure or Method
Event Date 06/03/2019
Event Type  Malfunction  
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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 rd
hartland WI 53029
Manufacturer Contact
meg mucha
900 walnut ridge rd
hartland , WI 53029
2629123570
MDR Report Key8748292
Report Number2183926-2019-00022
Device Sequence Number1
Product CodeLLZ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/03/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/01/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCADSTREAM V6.2.2.1184
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 Received06/03/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/18/2019
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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