Description of Event or Problem · 0
A CARDIAC CT IMAGING DEVICE, ARINETA SPOTLIGHT DUO EXPERIENCED A FAILURE DURING PATIENT SCANNING. THE SYSTEM INTERMITTENTLY LOST IMAGE RECONSTRUCTION CAPABILITY MID-EXAM, FORCING SCAN REPETITION AND INCREASING RADIATION DOSE TO THE PATIENT. THE ISSUE HAS OCCURRED IN MULTIPLE CASES, RESULTING IN WORKFLOW DELAYS AND PATIENT RESCHEDULING. ALSO, THE SYSTEM IS UNRELIABLE IN WHICH THE STAFF QUESTIONS THE RADIATION DOSE AND QUALITY OF EXAMS. THERE IS ALSO A ARTIFACT ON THE IMAGES IN WHICH THE COMPANY HAS YET TO ADDRESS. ISSUE HAS BEEN REPORTED TO THE COMPANY (ARINETA) HOWEVER THE COMPANY HAS YET TO ADDRESS THE ISSUE IN AN APPROPRIATE MANNER. THEIR CLINICAL TEAM MENTIONED THERE IS NOTHING THEY CAN DO ABOUT IT. UNFORTUNATELY, ONE PATIENT WAS MISDIAGNOSED DUE TO THE ARTIFACT AND HAD TO HAVE MULTIPLE OTHER UNNECESSARY TESTS. THE COMPANY CEO WAS MADE AWARE TO MY KNOWLEDGE. OUR FACILITY HAS HEARD MULTIPLE PROBLEMS WITH THE SAME SYSTEM ACROSS THE COUNTRY, INCLUDING ONE OUR FACILITY HEARD ABOUT AT (B)(6).