QUALITY ELECTRODYNAMICS

Description of Event or Problem

NO EVENT HAS OCCURRED AND A RISK ASSESSMENT HAS SHOWN THAT THE LIKELIHOOD OF AN EVENT OCCURRING DUE TO THE IDENTIFIED PRODUCT ISSUE IS NEGLIGIBLE. HOWEVER, A NONCONFORMING DEVICE THAT HAS BEEN DISTRIBUTED TO THE FIELD HAS BEEN IDENTIFIED AND IS THEREFORE BEING REPORTED. DURING PRODUCT INCOMING INSPECTION ON (B)(6) 2019 OF SIEMENS KNEE COIL FRAME SUBASSEMBLY (P/N 2000433) IT WAS DISCOVERED THAT THE PUSH BUTTON COMPONENT (P/N 3000830) CONTAINED NONCONFORMING FERROUS MAGNETIC MATERIAL IN THE THREADED POST. SUBSEQUENT INVESTIGATION WITH THE SUPPLIER INDICATED OTHER POTENTIALLY AFFECTED PART NUMBERS, SOME OF WHICH HAD BEEN DISTRIBUTED IN FINISHED DEVICES OUTSIDE QED TO THEIR DISTRIBUTOR, SIEMENS HEALTHINEERS. A COIL FRAME PUSH BUTTON CONTAINING NONCONFORMING FERROUS MATERIAL WILL PRODUCE NOTICEABLE DISTORTION WHEN USED IN AN MRI SCANNER. THE RISK OF THE FERROUS PART COMING OUT OF THE COIL FRAME AND PULLED INTO THE MRI DURING A SCAN WAS ALSO ASSESSED AND FOUND TO BE REMOTE. THOUGH SUCH AN OCCURRENCE COULD HAVE POTENTIALLY SERIOUS EFFECTS, IN ORDER TO PULL THE PART OF THE FRAME THE FORCE OF THE MAGNET WOULD HAVE TO BE AT LEAST FIFTY (50) TIMES STRONGER THAN IT IS IN THE MRI SYSTEMS WHERE THIS COIL IS USED. THE RISK ASSESSMENT IS ATTACHED TO THIS SUBMISSION. THE ASSESSMENT HAS CONCLUDED THAT THE RISKS ASSOCIATED WITH FRAME SUBASSEMBLIES CONTAINING FERROUS MATERIAL IN THE PUSH BUTTON ARE ACCEPTABLE AS DEFINED IN QED PROCEDURE SOP002, RISK MANAGEMENT AND IN ACCORDANCE WITH ISO 14971, MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES. HOWEVER, QED PLANS TO COMPLETE 100% CORRECTION OF THE POTENTIALLY IMPACTED COIL FRAMES THROUGH COMPONENT INSPECTION AND REPLACEMENT TO FULLY MITIGATE THE MATERIAL NON-CONFORMANCE. A CORRECTION AND REMOVAL HAS BEEN SUBMITTED PER 21 CFR PART 806.