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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 Problem Computer Software Problem (1112)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2016
Event Type  Malfunction  
Manufacturer Narrative

Merge healthcare is further investigating the allegation from the customer to determine if any corrections or corrective actions are necessary.

 
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, a report was provided with a request for help with structured reports (sr) by a customer using merge unity pacs who was attempting to create a template for multiple fetus exams. The merge unity structured report (sr) is not separating fields for ultrasound (us) obstetric (ob) exams with twins(aka multiple fetus exams). With merge unity pacs not reporting patient information as expected, there is a potential for mistreatment or misdiagnosis. The issue was identified during creation of the sr template and no patient involvement was reported. (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 Key6159982
MDR Text Key62339267
Report Number2183926-2016-00814
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/09/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/09/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNITY PACS R11.0.454.12402
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/09/2016
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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