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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 RADSUITE V8.30.7.9 P1
Device Problem Image Resolution Poor (1306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/04/2017
Event Type  Malfunction  
Manufacturer Narrative

Initial investigation findings determined that the site was utilizing new storage and optimal image/data compression rules were not being applied when the study was transferred to the archive. The storage rules have been resolved. Merge healthcare is continuing to investigate the customer's allegation to determine if any additional corrections or corrective actions are required. This is not hardware.

 
Event Description

The merge radsuite application provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. The system displays traditional 2d and reconstructed 3d radiological images using web-enabled viewers over both local and wide area networks. A customer reported to merge healthcare support on (b)(6) 2017 that there were "bad images pink/gren/yellow/red" for an ultrasound image that was being viewed from the archive. The customer site has not reported any patient safety concerns or delays, however if the images are blurry or are not considered to be diagnostic quality, there is a potential for patient harm, delay in treatment or diagnosis. (b)(4).

 
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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
meg mucha
900 walnut ridge drive
hartland, WI 53029
2629123570
MDR Report Key6302026
MDR Text Key66553502
Report Number2183926-2017-00028
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK05328124
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/03/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberRADSUITE V8.30.7.9 P1
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2017
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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