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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE UNITY PACS PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ

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MERGE HEALTHCARE MERGE UNITY PACS PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ Back to Search Results
Model Number UNITY PACS 12.0.4
Device Problems Computer Software Problem (1112); Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2020
Event Type  malfunction  
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) 2020, the customer reported receiving an exam report with no report body to (b)(6) health imaging on the same day. Troubleshooting from (b)(6) health imaging support found that there were no patient demographics, body, or conclusion data included in the report file. There was a report save event in the audit trail. Using the revision button from the dictation dialog box, the report template was re-generated and the report was then viewable as expected. This has the potential to delay patient treatment and/or diagnosis. There have been no reports of patient injury or harm as a result of this issue. Reference complaint (b)(4).
 
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Brand NameMERGE UNITY PACS
Type of DevicePICTURE ARCHIVING AND COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge drive
hartland, wi
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge drive
hartland, wi
Manufacturer Contact
brian bell
75 binney street
cambridge, ma 
3540189
MDR Report Key10227697
MDR Text Key199899619
Report Number2183926-2020-00021
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 07/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNITY PACS 12.0.4
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2019
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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