ICONNECT ENTERPRISE ARCHIVE
Received May 24, 2017 · Event occurred Apr 25, 2017
Report 2183926-2017-00111 · MDR key 6590012
Device
Generic name
Device, Digital Image Storage, Radiological
Manufacturer
Merge HealthcareModel number
ICONNECT ENTERPRISE ARCHIVE V9.40Product problems
- Communication or Transmission Problem
- Communication or Transmission Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
(B)(4) IS A WEB-BASED SOLUTION THAT PROVIDES A CONDUIT FOR A PIECE OF SOFTWARE TO REACH THE GREATEST NUMBER OF PLATFORMS. THE SYSTEM IS DESIGNED TO PROVIDE WORKFLOW INTEGRATION CAPABILITIES FOR HEALTHCARE ENTERPRISES. ON (B)(6) 2017, MERGE HEALTHCARE RECEIVED INFORMATION THAT IMAGES WERE NOT STREAMING TO THE WORKSTATION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE ACCOUNT ON 05/16/2017 THAT INDICATED THE ISSUE IMPACTED PATIENT CARE BECAUSE CARDIOLOGISTS WERE UNABLE TO REVIEW AND READ ECHO STUDIES ON PATIENTS. ADDITIONALLY, OLDER STUDIES ON PATIENTS HAVING CARDIAC CATHETERIZATIONS WERE UNAVAILABLE. MERGE TECHNICAL SUPPORT RESTARTED THE CUSTOMER'S IPADDRDR SERVICE ON THE (B)(4) AND THE ACCOUNT REPORTED RECEIVING IMAGES AS EXPECTED. IN ORDER TO PREVENT THE ISSUE FROM OCCURRING AGAIN, TECHNICAL SUPPORT HAS RECOMMENDED UPGRADING THE OPERATING SYSTEM AND PLATFORM. THIS ISSUE IS BEING REPORTED DUE TO THE POTENTIAL FOR HARM RELATED TO THE INABILITY OF THE MEDICAL PROFESSIONAL TO SEE NECESSARY CLINICAL DATA FOR DIAGNOSING AND/OR TREATING THE IMPACTED PATIENTS/STUDIES. NO DIRECT PATIENT HARM OCCURRED AS A RESULT OF THIS ISSUE. (B)(4).
Remedial action
- Modification/Adjustment