MERGE EYE CARE PACS

Additional Manufacturer Narrative

FURTHER INVESTIGATION INTO THE CUSTOMER'S ALLEGATION IS REQUIRED. INITIAL TROUBLESHOOTING EFFORTS COULD NOT CONFIRM A DEFICIENCY WITH THE EYE CARE PACS PRODUCT. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

EYE CARE PACS IS A COMPREHENSIVE SOFTWARE PLATFORM FOR THE IMPORT, INTEGRATION, AND REVIEW OF PATIENT DATA AND CLINICAL INFORMATION IN AN EYE CARE ENVIRONMENT. EYE CARE PACS ALLOWS FOR THE COLLECTION, MANAGEMENT, ENHANCEMENT, AND REVIEW OF PATIENT DEMOGRAPHICS, IMAGE DATA, DIAGNOSTIC DATA, AND CLINICAL REPORTS FROM A VARIETY OF MEDICAL DEVICES THROUGH EITHER A DIRECT CONNECTION WITH THE INSTRUMENTS OR THROUGH COMPUTERIZED NETWORKS. ON (B)(6)2017, MERGE HEALTHCARE RECEIVED INFORMATION, FROM AN ACCOUNT, THAT THE BROWSER IN EYE CARE PACS WAS NOT REFRESHING IN BETWEEN PATIENTS. AN INITIAL INVESTIGATION BY MERGE TECHNICAL SUPPORT SHOWED THE SUCCESSFUL TRANSMISSION OF PATIENT DATA FROM THE EMR (ELECTRONIC MEDICAL RECORD) SYSTEM. THIS ISSUE IS BEING REPORTED DUE TO THE POTENTIAL FOR HARM RELATED TO THE POSSIBILITY OF PATIENT INFORMATION BECOMING MIXED. NO PATIENT HARM HAS BEEN REPORTED AS A RESULT OF THIS ISSUE. (B)(4).

Additional Manufacturer Narrative

AN INVESTIGATION WAS OPENED AND ACCORDING TO DEVELOPMENT, THE ISSUE COULD NOT BE REPLICATED IN THE LATEST BUILD. THE ACCOUNT UPGRADED TO ANOTHER VERSION AND THE ISSUE WAS RESOLVED.