MERGE ICONNECT ENTERPRISE ARCHIVE

Additional Manufacturer Narrative

MERGE HEALTHCARE INVESTIGATED THE CUSTOMER'S ALLEGATION. BASED ON THE INFORMATION AND LOGGING DATA THAT WAS GATHERED, INFORMATION SUGGESTS THAT THE INCORRECT PATIENT NAME WAS SENT FROM THE IMAGING MODALITY TO THE MERGE HEALTHCARE DEVICE. MERGE HEALTHCARE (B)(4) ARCHIVE ACCEPTS DATA FROM THE MODALITIES THAT ARE SENT BY USERS. THIS ISSUE APPEARS TO BE A USER ERROR THAT OCCURED AT THE MODALITY.

Description of Event or Problem

MERGE (B)(4) CONSOLIDATES, STANDARDIZES AND ARCHIVES DICOM AND NON-DICOM IMAGES AND DATA FROM DISPARATE PACS, SPECIALTIES AND SITES. (B)(4) WORKS WITH MERGE RADSUITE WHICH IS AN APPLICATION THAT PROVIDES A MEANS TO DISTRIBUTE, DISPLAY, AND STORE DIAGNOSTIC-QUALITY MEDICAL IMAGES IN ELECTRONIC FORMAT. THE SYSTEM DISPLAYS TRADITIONAL 2D AND RECONSTRUCTED 3D RADIOLOGICAL IMAGES USING WEB-ENABLED VIEWERS OVER BOTH LOCAL AND WIDE AREA NETWORKS. ON (B)(6) 2016 A CUSTOMER REPORTED TO MERGE HEALTHCARE SUPPORT THAT THE NAME ON A PATIENT'S STUDY HAD CHANGED. THE ISSUE WAS READILY APPARENT TO THE USER DUE TO THE WORKFLOW AT THE SITE IS TO HAVE THE TECHS CHECK IN RADSUITE THAT THE PAPERWORK ATTACHED TO THE STUDY IS CORRECT. DURING THIS PROCESS THE CUSTOMER NOTICED THAT THE NAME WAS DIFFERENT THAN EXPECTED. WITH AN INCORRECT NAME APPEARING ON A PATIENT'S REPORT THERE IS A POTENTIAL FOR AN INCORRECT DIAGNOSIS AND/OR TREATMENT. HOWEVER, THE CUSTOMER DID NOT ALLEGE ANY PATIENT INJURY AS A RESULT OF THIS ISSUE. (B)(4).