COMBIDIAGNOST R90

Description of Event or Problem

IT WAS REPORTED THAT THE FOOTREST HAD COME LOOSE. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

Additional Manufacturer Narrative

REFERENCE ID: (B)(6). COMBIDIAGNOST R90 IS A DIGITAL RADIOGRAPHY AND FLUOROSCOPY SYSTEM. IF THE FOOTREST IS NOT PROPERLY LOCKED INTO PLACE ON BOTH SIDES, IT MAY SLIDE OFF THE TABLE WHEN THE TABLE IS TILTED TO THE VERTICAL POSITION. PHILIPS RECEIVED A COMPLAINT REGARDING A COMBIDIAGNOST R90 SYSTEM INDICATING THAT THE TABLE MOVED INTERMITTENTLY WHILE BEING REPOSITIONED FROM THE HORIZONTAL TO THE VERTICAL POSITION AND THAT THE FOOTREST HAD COME LOOSE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO PATIENT OR USER INJURY OCCURRED. THE FIELD SERVICE ENGINEER (FSE) VISITED THE SITE, AND THE REPORTED ISSUE COULD NOT BE REPRODUCED. IT WAS CONFIRMED THAT THE FOOTREST ITSELF HAD NO DEFECT; IT HAD SIMPLY NOT BEEN PROPERLY ATTACHED BY THE USER. BASED ON THE AVAILABLE INFORMATION, THE FOOTREST BECAME LOOSE BECAUSE IT WAS NOT PROPERLY ATTACHED. NO MALFUNCTION OF THE FOOTREST WAS IDENTIFIED.