inforMED
MalfunctionLMB

ISITE RADIOLOGY

Received Feb 18, 2005 · Event occurred Jan 4, 2005

Report 2954704-2005-00001 · MDR key 577816

Device

Generic name

Picture Archiving And Communication

Manufacturer

Stentor, Inc.

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Image Display Error/Artifact

Patient

*

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THE STENTOR ISITE SYSTEM SUPPORTS THE CREATION OF PRESENTATION STATES. THE USE OF THE PRESENTATION STATE FEATURE ALLOWS USERS TO MAKE WINDOW WIDTH/LEVEL CHANGES, RE-SORT SERIES DISPLAY ORDER ON THE EXAM RACK, MAKE MEASUREMENTS/ANNOTATIONS, SELECT KEY IMAGES FROM THE ORIGINAL DICOM STUDIES, AND SAVE THOSE MODIFICATIONS BACK TO THE ISITE SERVER FOR OTHER USERS TO VIEW. AFTER A CUSTOMER REPORTED AN ISSUE WITH A PRESENTATION STATE EXAM, A PROBLEM WAS IDENTIFIED; IF A PRESENTATION STATE IS CREATED ON A MULTI-FRAME EXAM BEFORE ALL OF THE IMAGES HAVE BEEN RECEIVED BY ISITE, UPON SUBSEQUENT VIEWING OF THAT EXAM WITH THE PRESENTATION STATE APPLIED, NEW IMAGES RECEIVED AFTER THE PRESENTATION STATE WAS CREATED ARE NOT ACCESSIBLE TO THE USER. INVESTIGATION SHOWED THAT IMAGES WERE ON ISITE, BUT DID NOT APPEAR IN PRESENTATION STATE DUE TO CREATION BY A TECHNOLOGIST BEFORE ALL STUDIES WERE RECEIVED. THERE ARE NO REPORTS OF PT INJURIES RELATED TO THIS PROBLEM.

Remedial action

  • Notification