RALCO COLLIMATOR IN XPLORER 1590 SYSTEM

Description of Event or Problem

A COLLIMATOR ATTACHED TO A CEILING MOUNTED X-RAY TUBE ASSEMBLY CAME LOOSE WHILE ADJUSTING BY THE TECHNOLOGIST. THE TECHNOLOGIST CAUGHT THE UNIT BEFORE IT FELL ON TO THE TABLE. NO PATIENT INVOLVED IN THE INCIDENT. THE RALCO R 302 COLLIMATOR WAS ATTACHED TO THE CEILING MOUNTED TUBE ASSEMBLY AS AN INTEGRATED COMPONENT OF THE XPLORER 1590 SYSTEM. IMAGING DYNAMICS INITIALLY DETERMINED THAT THIS IS NOT A REPORTABLE EVENT DUE TO THE ISOLATED NATURE OF THE INCIDENT AS WELL AS THE FACT THAT IT WAS A FAULTY INSTALLATION BY THE DEALER. THE HOSPITAL INDICATED THAT THEY HAVE SUBMITTED A MDR REPORT TO FDA ON THIS INCIDENT. HOWEVER, IMAGING DYNAMICS COULD NOT VERIFY THEIR SUBMISSION AND DECIDED TO SEND THIS REPORT AFTER DISCUSSION WITH FDA INSPECTOR WHO INSPECTED IMAGING DYNAMICS IN 2006.

Additional Manufacturer Narrative

THE RALCO R392 COLLIMATOR WAS RETURNED TO IMAGING DYNAMICS FOR INITIAL EVALUATION. IMAGING DYNAMICS DETERMINED THAT THIS WAS AN ISOLATED INSTALLATION ERROR AND NOT A MALFUNCTION OF THE DEVICE. THE COLLIMATOR WAS REPLACED WITH A DIFFERENT COLLIMATOR AS PER CUSTOMER'S REQUEST. THE ERROR WITH THE INSTALLATION WAS COMMUNICATED TO THE IMAGING DYNAMIC'S DEALER FOR THEIR CORRECTIVE / PREVENTIVE ACTION. THERE WAS NO REQUIREMENT TO INFORM THE MANUFACTURER SINCE THE PRODUCT MANUAL HAS VERY CLEAR INSTRUCTIONS ON INSTALLATION. IMAGING DYNAMICS INITIALLY DETERMINED THAT THIS IS NOT A REPORTABLE EVENT DUE TO THE ISOLATED NATURE OF THE INCIDENT AS WELL AS THE FACT THAT IT WAS A FAULTY INSTALLATION BY THE DEALER. THE HOSPITAL INDICATED THAT THEY HAVE SUBMITTED A MDR REPORT TO FDA ON THIS INCIDENT. HOWEVER, IMAGING DYNAMICS COULD NOT VERIFY THEIR SUBMISSION AND DECIDED TO SEND THIS REPORT AFTER DISCUSSION WITH FDA INSPECTOR WHO INSPECTED IMAGING DYNAMICS IN 2006.