AZURION 7 M20

Description of Event or Problem

I AM REPORTING THIS ON BEHALF OF MY HOSPITAL, (B)(6), AS THE MANUFACTURER OF THE DEVICE HAS REFUSED TO PLACE AN MDR, AND CURRENTLY DOES NOT HAVE A FIX. REPEATED IMAGE ARTIFACT DURING CARDIAC/VASCULAR PROCEDURES REQUIRING THE EQUIPMENT TO BE SHUT DOWN AND RESTARTED IN THE MIDDLE OF PATIENT CASES. THIS HAS BEEN A REPEATED ISSUE WITH MORE THAN 10 DIFFERENT OCCURENCES ON THIS SINGLE DEVICE. ON 1/31/2026 PHILIPS APPLIED A SOFTWARE PATCH, WHICH WAS INTENDED TO RESOLVE THE IMAGE ARTIFACT, HOWEVER IMMEDIATELY UPON USE IN THE FIRST PATIENT CASES ON (B)(6) 2026 THE IMAGE ARTIFACT RETURNED. THE THIRD CASE OF THE DAY REQUIRED THE EQUIPMENT TO BE FULLY SHUT DOWN, AND AN EXTERNAL C-ARM BE MOVED INTO THE ROOM TO CONTINUE THE CASE. PHILIPS HAS INDICATED THEY HAVE MORE THAN 10 OTHER UNITS WITH THE SAME ISSUE ACROSS THE US, BUT HAS NOT CREATED AN MDR, AND DOES NOT HAVE A RESOLUTION. THE NATURE OF THE EQUIPMENT FAILURE, THE TYPE OF PROCEDURE, AND THE HEALTH OF THE PATIENTS UNDER PROCEDURE COMBINE FOR A HIGHLY CRITICAL SITUATION.