ICONNECT ENTERPRISE ARCHIVE
Received Feb 16, 2016 · Event occurred Nov 15, 2015
Report 2183926-2016-00001 · MDR key 5437789
Device
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 WHILE READING A CT SCAN. THE ERROR MESSAGE IS PREVENTING THE RADIOLOGISTS FROM COMPARING THE CT STUDIES WITH PRIORS. THIS EVENT CAN IMPACT PATIENT CARE SINCE THE RADIOLOGISTS NEED TO HAVE RESULTS FOR STROKE ALERTS WITHIN 45 MINUTES. THE RADIOLOGISTS ARE HAVING TO REBOOT THE PC TO CLEAR THIS ERROR. THE CUSTOMER DID NOT REPORT A SERIOUS INJURY TO THE PATIENT. (B)(4).
Remedial action
- Recall