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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 MERGE UNITY PACS R11.0.5
Device Problem Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/02/2019
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. Troubleshooting from unity support found that there was a reported generated, however the document was not associated correctly to the exam. The exam was generated again by the site and the they confirmed that the exam was able to be re-read without incident. No further action required at this time.
 
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) 2019 the customer reported an exam was marked read, however, there is no exam report. The report was saved, but not associated properly with the exam. A cause of the failed association was not able to be determined. An investigation showed the report did not upload successfully and had to be read again by the doctor. There was no reported adverse event to the patient. However, 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. Reference complaint number: (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 Key8531352
MDR Text Key145617353
Report Number2183926-2019-00017
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 Other Health Care Professional
Type of Report Initial
Report Date 04/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE UNITY PACS R11.0.5
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 Received04/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2017
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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