ICONNECT ENTERPRISE ARCHIVE

Additional Manufacturer Narrative

AN INITIAL INVESTIGATION HAS DETERMINED THAT THIS ISSUE IS OCCURRING DUE TO THE WAY EA STORED SOME OF THE CUSTOMER'S IMAGES. WHEN TRYING TO OPEN THE IMAGES IN PACS THEY WERE "BLACK" AND NOT VIEWABLE. THE MERGE EA (ENTERPRISE ARCHIVE) MORPHER THAT WAS IN PLACE ESSENTIALLY ALTERED DICOM TAGS FOR VARIOUS REASONS. MERGE HEALTHCARE SUPPORT IS WORKING WITH THE CUSTOMER TO CHANGE THE MORPHER TO ENSURE THAT TOMOGRAPHY IMAGES ARE STORED AND CAN BE RETRIEVED WITHOUT APPEARING AS BLACK.

Description of Event or Problem

MERGE ICONNECT ENTERPRISE ARCHIVE (ICEA) CONSOLIDATES, STANDARDIZES AND ARCHIVES DICOM AND NON-DICOM IMAGES AND DATA FROM DISPARATE PACS, SPECIALTIES AND SITES. ICEA WORKS WITH MERGE PACS WHICH IS A PICTURE ARCHIVING COMMUNICATION SYSTEM THAT IS INTENDED TO CREATE AND DISPLAY TWO DIMENSIONAL AND THREE DIMENSIONAL IMAGES OF ANATOMY FROM A SERIES OF DIGITALLY ACQUIRED IMAGES. PACS IS DESIGNED AND MARKED FOR SOFT COPY READING, COMMUNICATION AND STORAGE OF STUDIES PRODUCED BY DIGITAL MODALITIES. ON (B)(6) 2016 A CUSTOMER REPORTED TO MERGE HEALTHCARE SUPPORT THAT TOMO STUDIES RETRIEVED FROM THE EA (ENTERPRISE ARCHIVE) INTO MERGE PACS ARE VIEWING AS "BLACK." AN INVESTIGATION DETERMINED THAT THE TOMOGRAPHY IMAGES RETRIEVED IN PACS ARE DISPLAYING "BLACK" BECAUSE THE SITE WAS USING CUSTOMER MANAGED MORPHERS THAT WAS HANDLING PIXEL DATA VALUES DIFFERENTLY THAN EXPECTED. DUE TO THE IMAGES BEING "BLACK" AND NOT VIEWABLE, THERE IS A POTENTIAL FOR A DELAY IN PATIENT TREATMENT OR DIAGNOSIS OR PATIENT HARM. HOWEVER, THERE WERE NO REPORTS OF DELAYS IN PATIENT TREATMENT OR DIAGNOSIS. THERE WERE NO REPORTS OF PATIENT HARM. (B)(4).

Additional Manufacturer Narrative

MDR 2183926-2016-00767-001 ((B)(4)). THIS SUPPLEMENTAL REPORT IS SUBMITTED TO THE FDA IN ACCORDANCE WITH THE APPLICABLE REGULATIONS AND AS INDICATED BY MERGE HEALTHCARE IN THE INITIAL REPORT SUBMITTED 10/18/2016. DURING TROUBLESHOOTING EFFORTS BETWEEN THE CUSTOMER AND MERGE TECHNICAL SUPPORT, IT WAS FOUND THAT THIS ISSUE WAS OCCURRING DUE TO THE WAY EA STORED THE IMAGES. WHEN TRYING TO OPEN THE IMAGES IN PACS THEY WERE "BLACK" AND NOT VIEWABLE. THE TOMOS RETRIEVED IN PACS ARE DISPLAYING "BLACK" BECAUSE THE SITE WAS USING CUSTOMER MANAGED MORPHERS THAT USED A TAG PAST THE PIXEL DATA TAG. THERE WERE NO REPORTS OF DELAYS IN PATIENT TREATMENT OR DIAGNOSIS. THERE WERE NO REPORTS OF PATIENT HARM. DUE TO THE IMAGES BEING "BLACK" AND NOT VIEWABLE, THERE IS A POTENTIAL FOR A DELAY IN PATIENT TREATMENT OR DIAGNOSIS OR PATIENT HARM. SUPPORT HAS CHANGED MORPHERS TO FIRE ON IF PATIENT ID EXISTS, NOT BASED ON PORT. REVISED INFORMATION CONTAINED IN THIS SUPPLEMENTAL REPORT INCLUDES THE FOLLOWING: UPDATED CONTACT OFFICE - NAME/ADDRESS. DATE NEW INFORMATION RECEIVED BY MANUFACTURER; INDICATION THAT THIS IS FOLLOW-UP REPORT 001; INDICATION OF MALFUNCTION AS REPORTABLE EVENT; INDICATION OF ADDITIONAL INFORMATION AND DEVICE EVALUATION. INDICATION THAT THE DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT EVALUATED BY MANUFACTURER. EVALUATION CODES FROM CONCLUSION CODE: CONCLUSION CODE 12 DESIGN DEFICIENCY. INDICATION OF ADDITIONAL MANUFACTURER INFORMATION IS CONTAINED IN THIS FOLLOW-UP REPORT.