DIGITALDIAGNOST 4.1 CHEST / EMERGENCY

Additional Manufacturer Narrative

REFERENCE ID: (B)(4). THE DIGITAL DIAGNOST 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, 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 INTRODUCED 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 DIGITAL DIAGNOST 4.X INDICATING THAT THE STITCHING STAND HYDRAULIC RAM HAS COME LOOSE. THE DEVICE WAS NOT IN CLINICAL USE, AND THERE WAS NO HARM TO THE PATIENT OR USER. THE REMOTE SERVICE ENGINEER (RSE) PERFORMED ANALYSIS AND CONCLUDED THAT THE REPORTED ISSUE INVOLVED THE PATIENT STITCHING SUPPORT ACCESSORY, WHERE THE BRAKE CYLINDER BECAME DETACHED FROM THE BASE OF THE STAND WHILE THE EQUIPMENT WAS OUTSIDE CLINICAL USE DURING CLEANING ACTIVITIES. INVESTIGATION CONFIRMED THAT THE BRAKE CYLINDER HAD COME OFF THE BASE BECAUSE THE MOUNTING AREA WHERE THE BRAKE CYLINDER SCREWS ATTACH SHOWED SIGNS OF WEAR, WHICH MAY HAVE REDUCED THE ABILITY TO FIRMLY SECURE THE SCREWS. NO EVIDENCE WAS IDENTIFIED TO INDICATE THAT THE HYDRAULIC BRAKE ITSELF WAS DEFECTIVE. AT THE TIME OF THE EVENT, THE CUSTOMER REPORTED THAT THE STITCHING STAND BRAKE HAD BECOME DISCONNECTED FROM THE FRAME, REQUIRING THE BASE OF THE STITCHING STAND TO BE LOWERED MANUALLY. ALTHOUGH THIS AFFECTED NORMAL ACCESSORY OPERATION, PATIENT IMPACT WAS NOT IDENTIFIED, AS THE STAND COULD STILL BE MANUALLY LOWERED BY THE RADIOGRAPHER IF STITCHING WAS REQUIRED. THE CUSTOMER ALSO HAD ANOTHER PATIENT STITCHING SUPPORT AVAILABLE FOR CONTINUED USE. DURING ONSITE SERVICE, THE ATTACHMENT MECHANISM CONNECTING THE BRAKE TO THE STAND WAS UNSCREWED, REATTACHED, AND SECURED. FUNCTIONAL TESTING AND VERIFICATION WERE SUBSEQUENTLY PERFORMED AND DOCUMENTED IN THE TEST AND VERIFICATION REPORT, CONFIRMING THAT THE BRAKE OPERATED AS INTENDED. FOLLOWING SUCCESSFUL VERIFICATION, THE DEVICE WAS RETURNED TO FULL FUNCTIONALITY. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS WEAR AND TEAR. THE REPORTED PROBLEM WAS CONFIRMED BY THE CUSTOMER.

Description of Event or Problem

IT WAS REPORTED THAT THE STITCHING STAND HYDRAULIC RAM HAS COME LOOSE. THE DEVICE WAS NOT IN CLINICAL USE, AND THERE WAS NO HARM TO THE PATIENT OR USER.