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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 R11.0.1
Device Problems Loss of Data (2903); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/09/2016
Event Type  malfunction  
Manufacturer Narrative
An investigation done by merge healthcare determined that if a report was saved too quickly after opening the exam, the report would not save successfully as expected. The user must save the report after the report template has completed building in order to ensure that the report saves successfully.
 
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 report for an exam was missing. After further investigation by merge support, it was determined that a report was created & saved by the radiologist. However the report was missing. The system crashed before the report was saved to the server. The merge support technician was not able to recover the report or find the word document file for the report. Therefore, the report was lost and needed to be re-dictated. There was no reported adverse event to a patient. However, reports needing to be re-dictated has the potential to delay patient 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 Key5938396
MDR Text Key54285960
Report Number2183926-2016-00716
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 08/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNITY PACS R11.0.1
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 Received08/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2015
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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