inforMED
MalfunctionLMB

ICONNECT ENTERPRISE ARCHIVE

Received Feb 16, 2016 · Event occurred Jul 27, 2015

Report 2183926-2015-00138 · MDR key 5437880

Device

Generic name

Image Archive

Manufacturer

Merge Healthcare

Model number

9.1.2

Product problems

  • Patient Data Problem
  • Patient 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.

Description of Event or Problem

CUSTOMER REPORTED THAT PRIORS ARE FAILING TO RETRIEVE BACK TO FACILITY IMAGE CACHE (FIC) FOR ONE PATIENT. THE PACS ADMIN RETRIEVED THE PRIORS MANUALLY. USER USED QC FUNCTION TO MAKE A CHANGE IN THE DATA AND INADVERTENTLY CONNECTED THE STUDIES TO ANOTHER PATIENT. FURTHER ANALYSIS HAS FOUND THAT AT SOME POINT, THE CUSTOMER MODIFIED A GROUP OF STUDIES ON THE LONG TERM ARCHIVE (LTA) AT THE SITE WHICH RESULTED IN THE STUDIES BEING PLACED UNDER AN INCORRECT PATIENT. (B)(4).