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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE UNITY PACS PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ,

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MERGE HEALTHCARE MERGE UNITY PACS PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ, Back to Search Results
Model Number UNITY PACS R11.1.1.1
Device Problem Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2016
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 a customer contacted merge healthcare on (b)(6) 2016 and reported seeing a message that a report did not cross to their radiology information system (ris) system (epic). After noticing the visit number did not match, the customer corrected it in merge unity and tried to resend. When the report opened, it was blank. The customer was unable to view the report. The merge healthcare unity support technologist placed a blank word document in the report directory on the image server. This allowed the exam to be re-read by the physician and the report saved and was accessible. (b)(4).

 
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Brand NameMERGE UNITY PACS
Type of DevicePICTURE AND ARCHIVING COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ,
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 Key6207897
MDR Text Key63368213
Report Number2183926-2016-00823
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 USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/28/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/27/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNITY PACS R11.1.1.1
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 Received09/27/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/29/2016
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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