ON 10/06/2016, THE CUSTOMER REPORTED THAT ONCE THE ARCHIVING ISSUE DID NOT RESOLVE THE INABILITY TO CAPTURE IMAGES, THE ACCOUNT PURCHASED A USB CARD. A NEW USB CARD DID NOT RESOLVE THE ISSUE. AT THIS TIME, MERGE HEALTHCARE HAS SHIPPED THE CUSTOMER ADDITIONAL HARDWARE COMPONENTS IN AN ATTEMPT TO RESOLVE THE ISSUE. ACCORDING TO THE CUSTOMER, THEIR SYSTEM IS TWELVE(12) YEARS OLD. THE SYSTEM HAS A NEW CAMERA AND IS OPERATING ON AN UPDATED OPERATING SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER BUT HAS NOT BEEN RECEIVED REGARDING THE RESOLUTION. MERGE HEALTHCARE CONTINUES TO WORK WITH THE CUSTOMER IN AN ATTEMPT TO RESOLVE THEIR ISSUE.
D
Patient 1
MERGE EYE STATION IS INTENDED TO BE USED IN CONJUNCTION WITH EXISTING OPHTHALMIC FUNDUS CAMERAS TO TAKE IMAGES OF THE EYE, PERFORM FLUORESCEIN ANGIOGRAPHY, RED FREE, COLOR AND ICG STILL-IMAGE PHOTOGRAPHY AS WELL AS VIDEO IMAGING. ON 09/27/2016, MERGE HEALTHCARE WAS NOTIFIED BY A CUSTOMER THAT IMAGES COULD NOT BE CAPTURED ON AN EYE STATION. MERGE HEALTHCARE SUPPORT INVESTIGATED THE CUSTOMER'S ALLEGATION AND FOUND THAT PATIENT RECORDS HAD NOT BEEN ARCHIVED, LEADING TO PROBLEMS WITH MEMORY WHICH IMPACTS THE ABILITY TO CAPTURE IMAGES. HOWEVER, THE CUSTOMER REPORTED THAT EVEN AFTER RECORDS WERE ARCHIVED THEIR ISSUE WAS NOT RESOLVED. MERGE HEALTHCARE CONTINUES TO WORK WITH THE CUSTOMER TO RESOLVE THEIR ISSUE. ON 10/06/2016, THE CUSTOMER REPORTED THAT BECAUSE THE SYSTEM HAS BEEN UNABLE TO CAPTURE IMAGES, PATIENTS WERE RESCHEDULED TO A LATER DATE, LEADING TO A POSSIBLE DELAY IN DIAGNOSIS AND/OR TREATMENT. NO DIRECT PATIENT HARM HAS BEEN REPORTED AT THIS TIME. (B)(4).