inforMED
MalfunctionLMB

ICONNECT ENTERPRISE ARCHIVE

Received Feb 16, 2016 · Event occurred Nov 9, 2015

Report 2183926-2016-00002 · MDR key 5437905

Device

Generic name

Archiver

Manufacturer

Merge Healthcare

Model number

10.0.2

Product problems

  • Device Issue
  • Device Issue

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR. DEVELOPMENT ASSESSED AND IMPLEMENTED A FIX AT THE CUSTOMER SITE. CUSTOMER REPORTED NO LONGER SEEING THE ERROR MESSAGE.

Description of Event or Problem

ICONNECT ENTERPRISE ARCHIVE A VENDOR NEUTRAL ARCHIVE FOR STORAGE AND COMMUNICATIONS OF MEDICAL IMAGES AND DATA. A CUSTOMER WAS MIGRATING FROM RADSUITE TO MERGE PACS. DURING THE MIGRATION, IMAGE LOAD ERRORS WERE OCCURRING ON STUDIES AFTER THE HALF FOLDER TOOL WAS RAN. CUSTOMERS MIGRATING FROM RADSUITE TO MERGE PACS WILL SEE THIS ISSUE FOR ANY DATA STORED PRIOR TO ICONNECT ENTERPRISE ARCHIVE VERSION 8.X. THIS ISSUE CAUSES IMAGE LOAD ERRORS IN THE PACS VIEWER PREVENTING A USER FROM VIEWING PRIORS. THE CUSTOMER DID NOT REPORT A SERIOUS INJURY TO THE PATIENT. (B)(4).