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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 R11.2.2
Device Problem Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2019
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. The merge healthcare unity investigation showed the report did not upload successfully, and will have to be recreated. To resolve this issue, the exam was re-read by the doctor. 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) 2019 the customer reported an exam ( exam date 3/5/19) was marked read on 3/5/19, however, exam report could not be found. An investigation showed the report did not upload successfully. The report word template was created and the exam was re-read by the doctor on (b)(6) 2019. 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-(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 Key8484234
MDR Text Key141086941
Report Number2183926-2019-00012
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 health professional,user faci
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 03/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNITY PACS R11.2.2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/28/2018
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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