BUCKY WALL STAND FAMILY

Additional Manufacturer Narrative

REF COMP#(B)(4). INVESTIGATION RESULT: - ON 01/07/2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION ENGINEER TROUBLESHOT THE SYSTEM AND ORDERED THE ION CHAMBER (8167538) AND D800 BOARD. ON 01/13/2025 SAME ENGINEER PERFORMED THE SERVICE, REPLACING THE ION CHAMBER, RECALIBRATING THE AEC, RESETTING THE IP ADDRESS OF THE FPD SE4 TO RESOLVE ERROR MD11024 AND VERIFIED THE SYSTEM WAS WORKING CORRECTLY.

Description of Event or Problem

ON 01/03/2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING A POLYDOROS RF RAD 80 DIGITAL GENERATOR. THE UPRIGHT BUCKY AUTOMATIC EXPOSURE SYSTEM IS CAUSING OVEREXPOSURE TO PATIENTS, AND AS A RESULT, MANUAL SETTINGS NEED TO BE USED INSTEAD TO ENSURE PROPER EXPOSURE LEVELS. EXPOSURE IS TERMINATED WHEN THE ION CHAMBER CELL REACHES THE PREDETERMINED VALUE OF X-RAY DOSE. IT WAS DISCOVERED THAT ION CHAMBER AS INSTALLED IN THE WALL BUCKY, WAS THE PART THAT FAILED. THE EVENT WAS DETERMINED TO BE AN ACCIDENTAL RADIATION OCCURRENCE. THE MANUFACTURER WAS NOTIFIED OF THE POTENTIAL ARO ON 03/05/2025. ADDITIONAL INVESTIGATION CONFIRMED THAT AEC EXPOSURE WAS MADE ON THE WALL BUCKY AND THE EXPOSURE FAILED TO TERMINATE WITHIN THE SPECIFIED TIME. THE OPERATOR THEN TERMINATED THE EXPOSURE. THE OPERATOR THEN USED A MANUAL TECHNIQUE TO COMPLETE THE EXAM. ON 03/12/25, UPON REVIEW OF ADDITIONAL INVESTIGATION, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE THAT THERE MAY BE A POTENTIAL ADVERSE EVENT. THE EVENT IS AN ACCIDENTAL RADIATION OCCURRENCE, HOWEVER, DUE TO THE UNKNOWN DURATION AND UNKNOWN AMOUNT OF CONTINUOUS EXPOSURE, FUJIFILM HEALTHCARE AMERICAS CORPORATION IS SUBMITTING THIS REPORT AS A POTENTIAL ADVERSE EVENT IN AN ABUNDANCE OF CAUTION.