PRECISION CRF

Additional Manufacturer Narrative

REFERENCE ID: (B)(4). PROXIDIAGNOST N90/ PRECISION CRF IS A MULTI-FUNCTIONAL GENERAL R/F SYSTEM. IT IS SUITABLE FOR ALL ROUTINE RADIOGRAPHY AND FLUOROSCOPY EXAMS, INCLUDING SPECIALIST AREAS LIKE ANGIOGRAPHY OR PEDIATRIC WORK, EXCLUDING MAMMOGRAPHY. PHILIPS RECEIVED A COMPLAINT FOR THE PROXIDIAGNOST N90 INDICATING THAT THE FOOT BOARD HAD A CRACK/DAMAGED. THE DEVICE WAS OUTSIDE OF USE AND THERE WAS NO PATIENT OR USER IMPACT REPORTED. THE FIELD SERVICE ENGINEER (FSE) VERIFIED THE REPORTED ISSUE. THE HEAD OF THE TABLE WAS FOUND TO BE BENT, AND THE UNDERLYING PLASTIC HAD BEEN PUNCTURED. IT WAS DETERMINED THAT AN OBJECT BECAME LODGED AT THE FRONT OF THE TABLE DURING MOVEMENT, CAUSING THE BENDING AND SUBSEQUENT DAMAGE. A GOOD FAITH EFFORT (GFE) WAS RAISED TO THE FSE, CONFIRMING THAT THE DAMAGE RESULTED FROM USER MISUSE OF THE TABLE. THE CUSTOMER DECLINED THE SERVICE RECOMMENDED BY THE FSE AND ACCEPTED RESPONSIBILITY FOR RESOLVING THE ISSUE THEMSELVES; THEREFORE, NO FURTHER INFORMATION COULD BE OBTAINED. BASED ON THE AVAILABLE INFORMATION AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED ISSUE WAS PHYSICAL MISUSE OF THE TABLE, WHERE AN OBJECT BECAME CAUGHT AT THE FRONT DURING MOVEMENT, RESULTING IN BENDING AND DAMAGE TO THE TABLE HEAD AND UNDERLYING PLASTIC. THIS ISSUE IS FURTHER TRENDED AND MONITORED.

Description of Event or Problem

IT WAS REPORTED THAT THE FOOT BOARD HAD A CRACK/DAMAGED. THE DEVICE WAS OUTSIDE OF USE AND THERE WAS NO PATIENT OR USER IMPACT REPORTED.