inforMED
MalfunctionLMB

ICONNECT ENTERPRISE ARCHIVE

Received Feb 16, 2016 · Event occurred Jul 23, 2015

Report 2183926-2016-00004 · MDR key 5437793

Device

Generic name

Archiver

Manufacturer

Merge Healthcare

Model number

9.4.0

Product problems

  • Data Problem
  • Data Problem

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. ENGINEERING HAS EVALUATED AND ASSESSED THIS DEVICE MALFUNCTION. A FIX HAS BEEN IMPLEMENTED IN VERSION 9.4.4.1

Description of Event or Problem

ICONNECT ENTERPRISE ARCHIVE A VENDOR NEUTRAL ARCHIVE FOR STORAGE AND COMMUNICATIONS OF MEDICAL IMAGES AND DATA. A CUSTOMER CALLED TO INFORM MERGE HEALTHCARE THAT AN ERROR MESSAGE IS DISPLAYING, WHICH PREVENTS THE RADIOLOGISTS FROM VIEWING PRIORS. THE RADIOLOGISTS ARE HAVING TO REMOVE PRIORS FROM AV AND WEBADMIN AND THEN TO PUSH IT FROM LONG TERM ARCHIVE. THE FREQUENCY OF THIS EVENT MAY RESULT IN A DELAY IN PATIENT CARE. THE CUSTOMER DID NOT REPORT A SERIOUS INJURY TO THE PATIENT. (B)(4).

Remedial action

  • Recall