COMBIDIAGNOST R90

Additional Manufacturer Narrative

REFERENCE ID: (B)(4). THE COMBIDIAGNOST R90 IS AN X-RAY UNIT INTENDED FOR CONTROLLED DIGITAL AND CONVENTIONAL FLUOROSCOPY AND RADIOGRAPHY PROCEDURES. WHEN THE FOOTREST IS NOT PROPERLY LOCKED INTO PLACE ON BOTH SIDES, IT MAY SLIDE OFF THE TABLE WHEN THE TABLE IS TILTED VERTICALLY. PHILIPS RECEIVED A COMPLAINT RELATED TO A COMBIDIAGNOST R90 SYSTEM INDICATING THAT THE FOOT SUPPORT PLACED ON THE PATIENT TABLE IN THE DIGESTIVE ROOM DID NOT FIT CORRECTLY AND THEREFORE COULD NOT BE SAFELY USED, AS IT COULD POSE A POTENTIAL RISK OF PATIENT FALLS. UPON INSPECTION, THE ISSUE WAS IDENTIFIED WITHIN THE FOOTREST ATTACHMENT COMPONENT ITSELF. TO PROPERLY SECURE THE FOOTREST TO THE PATIENT BOARD, THE SUPPORT MUST FIRST BE POSITIONED ONTO THE HOOK MECHANISM. ONCE ONE SIDE IS ENGAGED, THE ACCESSORY MUST THEN BE PUSHED INWARD FROM ONE SIDE OF THE BOARD SO THAT THE OPPOSITE SIDE LOCKS INTO PLACE. THE ISSUE WAS IDENTIFIED WHILE THE DEVICE WAS IN CLINICAL USE. NO PATIENT OR USER HARM OR IMPACT WAS REPORTED. THE REMOTE SERVICE ENGINEER (RSE) PERFORMED AN INITIAL ASSESSMENT AND SUSPECTED THAT THE ISSUE WAS ASSOCIATED WITH MISUSE OF THE ACCESSORY, RESULTING IN WEAR OF THE ATTACHMENT MECHANISM. ELECTROMEDICINE SERVICE WAS SUBSEQUENTLY CONTACTED TO ARRANGE REPLACEMENT OF THE FOOTREST ASSEMBLY. A FIELD SERVICE ENGINEER (FSE) LATER VISITED THE CUSTOMER SITE, REPRODUCED THE REPORTED ISSUE, AND ATTEMPTED MECHANICAL ADJUSTMENTS; HOWEVER, THE ATTACHMENT ANCHORS WERE FOUND TO BE WORN AND COULD NOT BE REPAIRED. AS A RESULT, REPLACEMENT OF THE FOOTREST ASSEMBLY WAS REQUIRED, AND A REPLACEMENT PART WAS ORDERED. A GOOD FAITH EFFORT (GFE) FOLLOW-UP WAS CONDUCTED, DURING WHICH THE FSE CONFIRMED THAT THE OBSERVED CONDITION WAS CONSISTENT WITH CONTINUOUS MISUSE LEADING TO WEAR AND TEAR OF THE ANCHORS. THE REPLACEMENT FOOTREST WAS SUBSEQUENTLY SHIPPED TO THE CUSTOMER SITE. BASED ON THE AVAILABLE INFORMATION AND INVESTIGATION RESULTS, THE REPORTED ISSUE WAS ATTRIBUTED TO CONTINUOUS MISUSE RESULTING IN PROGRESSIVE WEAR AND TEAR OF THE FOOTREST ATTACHMENT ANCHORS. THE AFFECTED COMPONENT WAS REPLACED TO RESTORE NORMAL FUNCTIONALITY.

Description of Event or Problem

IT WAS REPORTED THAT THE FOOT SUPPORT PLACED ON THE PATIENT TABLE IN THE DIGESTIVE ROOM DID NOT FIT CORRECTLY AND WAS DEEMED UNUSABLE, AS IT POSED A RISK OF PATIENT FALLS. INSPECTION REVEALED THE FAULT LAY WITHIN THE COMPONENT ITSELF. TO SECURE IT TO THE PATIENT BOARD, THE SUPPORT MUST FIRST BE POSITIONED ON THE HOOK; ONCE ONE SIDE IS ENGAGED, THE ACCESSORY MUST THEN BE PUSHED INWARD FROM ONE SIDE OF THE BOARD, SO THE OPPOSITE SIDE LOCKS INTO PLACE. THE ISSUE WAS IDENTIFIED DURING CLINICAL USE, BUT NO PATIENT OR USER IMPACT WAS REPORTED.