G10-01 GENTUITY HF-OCT IMAGING SYSTEM

Additional Manufacturer Narrative

LOGS SHOWED THE FLUSH-DETECTION ALGORITHM TRANSITIONED FROM NON-CLEAR TO CLEAR FRAMES WITHOUT DELAY, INDICATING NORMAL SOFTWARE BEHAVIOR. ANGIOSYNC ISSUES WERE TRACED TO A FAULTY USER-SUPPLIED ADAPTER. ISSUES WERE RESOLVED BY REPLACING THE CABLE. THE TRIGGER-DELAY COMPLAINT IS UNCONFIRMED; GENTUITY WILL MONITOR FOR RECURRENCE.

Description of Event or Problem

#1) WENT TO REVIEW MARCH CASES AT ADVOCATE AND NOTICED WHAT LOOKED LIKE TO ME ¿CATHETER DELAY TO TRIGGER¿. THIS SEEMED TO BE REPEATED IN SEVERAL CASES, DOWNLOADED 6 CASES FROM MARCH, AND 30 DAYS OF LOGS. DR (B)(6) HAD ALSO MENTIONED THE LAST TIME THAT I WAS THERE THAT HE WANTED ME TO TEACH HIM AGAIN HOW TO TRIGGER ON HIS OWN BECAUSE HE THOUGHT THAT THE CATHETER WAS TRIGGERING LATE AND HE WAS RUNNING OUT OF CONTRAST. # 2) AS I WAS REVIEWING CASES, I ALSO NOTICED SYNCHRONIZATION ERROR IN SEVERAL OF THE CASES. AND ANGIOSYNC WOULD BE ¿ON AND OFF¿ (ON FOR ABOUT 5 FRAMES, THEN OFF FOR ABOUT 5 FRAMES). I HAD BEEN TROUBLESHOOTING THIS ISSUE FOR A WHILE WITH ADVOCATES BIOMED DEPARTMENT AS WE THOUGHT IT WAS A CABLING ISSUE ON THEIR END, BUT WHEN WE REALIZED IT WASN¿T JUST LIMITED TO ONE ROOM, AND WAS GETTING WORSE AFTER THEY CHANGED CONNECTIONS.