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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE RADSUITE SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

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MERGE HEALTHCARE RADSUITE SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Model Number 8.30.6.1
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operational Issue (2914); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2015
Event Type  malfunction  
Manufacturer Narrative
Upon review of this customer issue, it was determined to be reportable as an mdr.
 
Event Description
Radsuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. A customer reported (case (b)(4)) that studies are storing but are also locking up. This was determined to be a potential safety issue in the event the information could not be available for review.
 
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Brand NameRADSUITE
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
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 dr.
hartland, WI 53029
2629123570
MDR Report Key5437795
MDR Text Key38218698
Report Number2183926-2016-00007
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053281
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 Number8.30.6.1
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 Received11/03/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2012
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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