DR 400

Description of Event or Problem

A CUSTOMER IN (B)(6) REPORTED TO AGFA, DURING NORMAL MOVEMENT OF THEIR DR 400 SYSTEM, THE COLLIMATOR WAS LOOSENED FROM THE SYSTEM. AGFA SERVICE RESPONDED AND COMPLETED CHECKS OF THE DR 400 SYSTEM. THE INVESTIGATION BY AGFA CONFIRMED THE ROOT CAUSE AS INCORRECT MOUNTING OF THE SYSTEM COLLIMATOR FLANGE. LOCAL SERVICE OBSERVED THE FLANGE WAS PARTLY BROKEN AND DENTING OF THE FLANGE LOCKING HOOKS WAS VISIBLE. THERE WAS NO CORROSION VISIBLE ON THE FLANGE. DUE TO INCORRECT MOUNTING OF THE FLANGE, THE MECHANICAL STRESS ON ONE SIDE OF THE FLANGE EXCEEDED THE MATERIAL STRENGTH. THIS LEAD TO THE BREAK IN THE FLANGE. AGFA LOCAL SERVICE HAS NOW CORRECTLY MOUNTED A COLLIMATOR FLANGE AND ALL LOCKS ARE SECURED ON THE FLANGE. THE UNIT IS NOW WORKING AS INTENDED AND NO FURTHER EVENTS HAVE BEEN REPORTED. THE DR 400 SYSTEMS ALREADY CONTAIN AN EXPLICIT CAUTION WARNING CONCERNING INSTALLATION OF THE MOUNTING FLANGE: "THE FLANGE MUST BE PLACED WITH THE LETTER "F" FACING TOWARD THE X-RAY TUBE PORT. INCORRECT POSITION MAY CAUSE THE COLLIMATOR AND FLANGE TO MALFUNCTION." "ENSURE THE SCREW HEAD IS INDEED CORRECT FOR THE FLANGE SELECTED. IT IS THE RESPONSIBILITY OF THE END-USER TO ENSURE ALL SAFETY MEASURES ARE IMPLEMENTED TO ENSURE THE SCREWS ARE OPTIMALLY TIGHTENED INCLUDING THE USE OF APPROPRIATE LOCKTITE." "TIGHTEN THE 4 SCREWS TO THE X-RAY TUBE HEAD SECURELY, STRICTLY ACCORDING TO THE INSTRUCTIONS OF THE X-RAY TUBE MANUFACTURER. DO NOT EXCEED 0.45 NM OF FORCE." THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USERS FOR THIS EVENT."