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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 R11.0.455.12641
Device Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/13/2016
Event Type  malfunction  
Manufacturer Narrative
An investigation (upax-3201) was conducted by the merge development team and determined that this could be a result of two things: the digate failing to compress or the digate freezing while incorporating. When the digate fails to compress, this means that potentially, the digate could try to load into memory, 8 images. If the images are large, and the physical memory on the machine in limited, the digate will run out of memory. The solution would be to configure the digate with few incorporation threads: 1 or 2 at most. When the digate is freezing while incorporating, the digate is actively trying to upload very large images to the pacs and failing repeatedly. The solution is to increase the time-out in internet information services (iis) and/or limit the number of incorporation threads in digate. This candidate version to fix this issue is 11. 2.
 
Manufacturer Narrative
This investigation is ongoing and not yet complete. A review of the merge unity user guides provided information on how to move exams online and sizing mammograms. However, did not reveal any information regarding troubleshooting or other anomalies/issues about moving exams online.
 
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. On (b)(6) 2016, merge was notified that a 3d mammogram exam was stuck on incorporating and was not able to be moved online to be read. An investigation done by merge determined that the patient's mammogram exam had 10 views, which was too large to cross over to the pacs system. The exam was deleted and resent, the recommended compression was applied to the images on the modality, the images were sent one at a time, and in addition, the third party modality vendor assisted in attempting to resend the images one at a time with no success. Merge determined that the images were too large, even after the compression and sending them one at a time. There was no reported adverse event to a patient. However, the radiologist decided to re-schedule the patient for a different exam, one view, 2d mediolateral oblique (mlo) view mammogram without tomography. Therefore, images that are too large to be sent from the modality to the pacs system has the potential to delay treatment and/or diagnosis. (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
michael diedrick
900 walnut ridge drive
hartland, WI 53029
2629123570
MDR Report Key5951750
MDR Text Key264916633
Report Number2183926-2016-00728
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 08/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNITY PACS R11.0.455.12641
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 Received02/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/22/2016
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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