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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 11.0.6
Device Problems Computer Software Problem (1112); Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2020
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 a "no object found" error when trying to open a report for dictation to ibm watson health imaging on (b)(6) 2020. Troubleshooting from ibm watson health imaging support found that the report folder was empty, causing the "no object found" error, and that there was a report save event present in the device audit trail. Ibm watson health imaging support regenerated the report template and saved it in dictated (did) status. The report was saved with the new template. The report was then readable. 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 Key10192498
MDR Text Key198685616
Report Number2183926-2020-00022
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 06/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNITY PACS 11.0.6
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2019
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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