DIGITALDIAGNOST 4.1 HIGH PERFORMANCE

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT SUPPORT PROBLEM. THE DEVICE WAS NOT IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

Additional Manufacturer Narrative

REFERENCE ID: (B)(4). THE DIGITALDIAGNOST 4.X IS A STATIONARY X-RAY SYSTEM FOR GENERAL RADIOGRAPHIC PURPOSES. FOR ANATOMIES THAT ARE LARGER THAN THE DETECTOR SIZE, IT IS POSSIBLE TO MAKE A SERIES OF EXPOSURES COVERING THE WHOLE ANATOMY (FOR EXAMPLE FULL SPINE OR FULL LEGS). THESE INDIVIDUAL IMAGES CAN BE "STITCHED" TOGETHER VIA THE SOFTWARE PROGRAM. FOR PROPER PATIENT POSITIONING AND SUPPORT, THE PATIENT CAN BE PLACED ON THE SO-CALLED STITCHING PATIENT SUPPORT OR STITCHING STAND (9890 010 87431), A PLATFORM WITH TWO HANDLES THAT THE PATIENT CAN HOLD ON TO DURING THE EXAMINATION. FOR THE EASE OF USE DURING TRANSPORTATION, THE PATIENT SUPPORT FOR STITCHING HAS WHEELS AND A FOLDING FOOTBOARD. THE FOOTBOARD IS CONNECTED TO THE FRAME VIA TWO HINGES AND A BRAKE CYLINDER. IT HAS TO BE FOLDED UP AND FIXED BY A HOOK FOR TRANSPORTATION, E.G. FROM ONE ROOM TO ANOTHER. THE BRAKE CYLINDER WAS INTRODUCED WITH FCO71200185 AND HAS THE TASK TO ENSURE THAT THE FOOTBOARD LOWERS ITSELF SLOWLY (WITHIN 5-7 SECONDS) WHEN THE HOOK IS RELEASED, TO PREVENT THE FOOTPLATE FROM FALLING ON THE FOOT OF A PERSON. IF THE OPERATOR STEPS ON THE FOOTBOARD WHILE IT IS STILL MOVING DOWN, THE MOUNTING OF THE BRAKE CYLINDER CAN BREAK, AND THE FOOTBOARD FALLS DOWN IMMEDIATELY. IN A WORST CASE, IT MAY HIT THE FOOT OF A PERSON AND BREAK A BONE. PHILIPS RECEIVED A COMPLAINT ON DIGITALDIAGNOST 4.X INDICATING THAT THE PATIENT SUPPORT PROBLEM. THE DEVICE WAS NOT IN CLINICAL USE AND THERE WAS NO HARM TO PATIENT OR USER. THE FIELD SERVICE ENGINEER (FSE) PERFORMED AN ANALYSIS AND CONCLUDED THAT THE SINGLE GAS SPRING MOUNTING PART BECAME DETACHED DUE TO DETERIORATION. AS A RESULT, THE GAS SPRING COULD NO LONGER REMAIN SECURELY IN PLACE. THE DETACHMENT OCCURRED WHILE THE SYSTEM WAS NOT IN CLINICAL USE. THE FSE REPLACED THE DEFECTIVE SINGLE GAS SPRING WITH A NEW ONE, WHICH CONSISTS OF TWO GAS SPRINGS. THE SYSTEM WAS THEN RETURNED TO CLINICAL USE BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS WEAR AND TEAR, WHICH LED TO DETERIORATION OF THE COMPONENT. THE REPORTED PROBLEM WAS CONFIRMED BY THE CUSTOMER.