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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

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MERGE HEALTHCARE MERGE UNITY PACS PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Back to Search Results
Model Number UNITY PACS R10.0.436.121
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/08/2017
Event Type  Malfunction  
Manufacturer Narrative

Merge healthcare is continuing to investigate the issue reported by the customer. A review of the merge unity user guides did not reveal any troubleshooting or other anomalies/issues regarding database/disk array guardian issues. A review of the complaint history indicates there are three similar complaints for this issue. Trending will continue to be monitored.

 
Event Description

Merge unity pacs 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. Merge healthcare was notified by a customer on 02/08/2017 that all users were not able to connect to the server. Testing and investigation by merge healthcare technical support determined that the site had been experiencing ongoing storage issues with their drives. In order to resolve this hardware storage issue, merge healthcare sent the customer six (6) new one terabyte (tb) drives. The new configuration would allow for distributing the pacs storage across multiple drives ensuring that free space and regular maintenance (defragging) would occur. However, during the on-site replacement installation, the array drive in the image server failed. The failed array was replaced. In the efforts of restoring the data, four exams were unable to be recovered. Therefore, each patient had to be re-scheduled for another mammogram exam at a later date. There is a potential for patients that require re-imaging due to data loss, to experience a delay in treatment and/or diagnosis that could lead to harm. At this time, there is no indication of an adverse event for the affected patients. (b)(4).

 
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Brand NameMERGE UNITY PACS
Type of DevicePICTURE ARCHIVING AND 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
2629123570
MDR Report Key6397966
MDR Text Key69850475
Report Number2183926-2017-00055
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK041935
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 02/08/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/11/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNITY PACS R10.0.436.121
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/30/2015
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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