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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 R11.0.454.12402
Device Problems Loss of Data (2903); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/10/2016
Event Type  malfunction  
Manufacturer Narrative
A review of the merge unity user guides did not reveal any troubleshooting or other anomalies/issues regarding missing reports or reports not saving. Merge healthcare is evaluating the complaint to determine if any corrections or corrective actions are required.
 
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. An investigation by merge support determined that a report was created and attempted to be saved on (b)(6) 2016 at 23:31, however, the report did not upload successfully to the server. It was noted that this report was for a stat ct chest/abdomen/pelvis. The merge support technician was not able to recover the report or find the word document file for the report that was read on (b)(6) 2016. Further investigation determined that the exam was re-read and the report was revised on (b)(6) 2016. 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 Key5942092
MDR Text Key54403039
Report Number2183926-2016-00715
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 08/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNITY PACS R11.0.454.12402
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 Received08/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2015
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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