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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS PICTURE ARCHIVING COMMUNICATION SYSTEM PACS

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MERGE HEALTHCARE MERGE PACS PICTURE ARCHIVING COMMUNICATION SYSTEM PACS Back to Search Results
Model Number MERGE PACS 7.0.2
Device Problems Communication or Transmission Problem (2896); Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2016
Event Type  Malfunction  
Manufacturer Narrative

Merge healthcare is continuing to investigate the issue and will determine if corrections or corrective actions are required.

 
Event Description

Merge pacs is a picture archiving communication system that is intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. Pacs is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities. On (b)(6) 2016 a customer reported that the communication notes were not saving. With merge pacs not saving communication notes as expected there is a potential for a delay in diagnosis or treatment that leads to harm. The customer did not allege an injury, the need for medical intervention, or adverse consequences as a result of the unretrievable images. (b)(4).

 
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Brand NameMERGE PACS
Type of DevicePICTURE ARCHIVING COMMUNICATION SYSTEM PACS
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge dr
hartland 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge dr
hartland WI 53029
Manufacturer Contact
mike diedrick
900 walnut ridge dr
hartland, WI 53029
2629123570
MDR Report Key6165569
MDR Text Key62385329
Report Number2183926-2016-00816
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK082144
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation RADIOLOGIC TECHNOLOGIST
Type of Report Initial,Followup
Report Date 02/22/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/11/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberMERGE PACS 7.0.2
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 Received11/11/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/29/2014
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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