PROXIDIAGNOST N90 REL 1.1

Description of Event or Problem

IT WAS REPORTED THAT THE SURFACE AREA OF THE TABLE FOOTREST WAS CRACKED. THE DEVICE WAS OUTSIDE CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

Additional Manufacturer Narrative

REFERENCE ID: (B)(4). PROXIDIAGNOST N90 IS A MULTIFUNCTIONAL RADIOGRAPHY AND FLUOROSCOPY SYSTEM INTENDED FOR ROUTINE RADIOGRAPHY AND FLUOROSCOPY EXAMINATIONS. PHILIPS RECEIVED A COMPLAINT REGARDING A PROXIDIAGNOST N90 SYSTEM INDICATING THAT THE SURFACE OF THE TABLE FOOTREST WAS CRACKED. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. NO PATIENT OR USER INJURY OCCURRED. THE REMOTE SERVICE ENGINEER (RSE) REPRODUCED THE REPORTED CONDITION WITH ASSISTANCE FROM THE CUSTOMER. A VISUAL INSPECTION OF THE FOOTREST CONFIRMED THE PRESENCE OF A CRACK IN THE FOOTREST SURFACE. THE INVESTIGATION DETERMINED THAT REPLACEMENT OF THE FOOTREST WAS REQUIRED. A REPLACEMENT FOOTREST WAS ORDERED AND SHIPPED TO THE CUSTOMER SITE. THE CUSTOMER ASSUMED RESPONSIBILITY FOR INSTALLATION AND SERVICING OF THE REPLACEMENT PART. THE CUSTOMER WAS ADVISED TO CONTACT PHILIPS IF ADDITIONAL SUPPORT IS REQUIRED, AT WHICH TIME A NEW SERVICE ORDER WILL BE CREATED. A GOOD FAITH EFFORT (GFE) WAS CONDUCTED WITH THE RSE. THE RSE CONFIRMED THAT THE CONDITION WAS CONSISTENT WITH MECHANICAL WEAR OF THE FOOTREST OVER TIME. BASED ON THE AVAILABLE INFORMATION, THE ISSUE WAS ATTRIBUTED TO NORMAL MECHANICAL WEAR OF THE FOOTREST. A REPLACEMENT FOOTREST WAS ORDERED AND SHIPPED TO THE CUSTOMER SITE.