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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 R11.1.2.3
Device Problems Computer Software Problem (1112); Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2018
Event Type  malfunction  
Manufacturer Narrative
Merge unity pacs is designed to display a message to the user when an exam report fails to upload to the image server. In this instance, there was no evidence that the physician received the message warning that the report did not upload. It was not possible to determine if the message displayed on the screen for the physician when the report was first read and saved. Unity investigation showed the database was updated but the report did not upload to the server. Audit trail showed the exam was read, approved and saved. The exam was re-read by the physician. Station logs had truncated, therefore were unavailable for review. No other review/investigation will be performed for cause.
 
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. On (b)(6) 2018, the pacs administrator reported that no report was displaying for 2 exams that had been read. The unity tech's investigation showed one report is missing since the exam was using a combined report. The audit trail does show a "report save" event. The unity tech's investigation showed the report did not upload successfully, and would have to be recreated. The audit trail does show a "report save" event. The work station's logs had truncated, and were unable to be reviewed. While images are available, a finalized report not being available for subsequent review by the patient's physician 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 Key7372895
MDR Text Key103928392
Report Number2183926-2018-00019
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
Report Date 02/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNITY PACS R11.1.2.3
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 Received02/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2017
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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