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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 11.1.2.PATCH5
Device Problems Computer Software Problem (1112); Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2018
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. Station logs were available for review. It was not possible to determine if the error message displayed on the screen for the doctor when the report was first read and saved notified the failure to upload. There was no evidence that report was saved. The unity support technician's investigation showed that the unity database was updated but the report did not upload. As a result of the finalized report being unavailable, the exam was re-read by a physician. 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 customer reported that the report was missing for an exam (dated (b)(6) 2018) that was dictated by the doctor on (b)(6) 2018. Merge technical support investigated the customer's allegation by reviewing the workstation logs for merge unity pacs. Technical support did identify a save event in the logs but there was no data uploaded and therefore the report was not available. The exam was required to be re-read by the physician. The exam was re-read on (b)(6) 2018. 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. Reference complaint (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 Key7454305
MDR Text Key106594510
Report Number2183926-2018-00029
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 03/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNITY PACS 11.1.2.PATCH5
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 Received03/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/24/2017
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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