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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE UNITY PACS PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM

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MERGE HEALTHCARE MERGE UNITY PACS PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM Back to Search Results
Model Number UNITY PACS R11.0.4
Device Problems Computer Software Problem (1112); Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2018
Event Type  malfunction  
Manufacturer Narrative
The investigation into this issue is active and ongoing. Unty pacs has discovered hd archive and burn to cd are corrupting images with large look up tables (luts). In the case of hd archive, the corruption goes unnoticed until the images are restored. Some images can be restored while other images cannot be viewed (invalid image). There are exam reports available for review for all exams. Merge healthcare is further investigating the allegation from the customer to determine if any corrections or corrective actions are necessary. On may 23, 2018 the lead unity support technician contacted the designated complaint handling unit (dchu) with additional information leading dchu to submit this issue to fda.
 
Event Description
Merge unity pacs is a medical image and information management system that is used for viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. A unity pacs administrator reported to merge technical support on (b)(6) 2018 that an invalid image format was found on an exam that was previously read by a radiologist. Upon initial review on april 27, 2018 it was believed this issue was related to the site's supplied storage vendor. The complaint remained open for additional information but was marked as "not reportable". On may 18, 2018 new information became available. The issue with the invalid image format was determined to be unity software related. While the exam report is available, the inability to restore an exam from long term storage for viewing could potentially result in a delay in care that could lead to harm. However, the customer did not allege any harm, serious injury or death as a result of this issue. (b)(4).
 
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Brand NameMERGE UNITY PACS
Type of DevicePICTURE AND ARCHIVING COMMUNICATIONS 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
meg mucha
900 walnut ridge drive
hartland, WI 53029
MDR Report Key7564155
MDR Text Key110460772
Report Number2183926-2018-00045
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041935
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 04/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNITY PACS R11.0.4
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2016
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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