UP-51MD

Description of Event or Problem

ON OCTOBER 24, 2006, SONY ELECTRONICS INC. RECEIVED MAUDE REPORT FROM FDA STATING THAT IN 2005, (MORE THAN 1 YEAR AGO) ONE OF OUR MEDICAL DEVICES, UP51MD VIDEO PRINTER, WAS OBSERVED SMOKING AND WAS CRACKED. PROMPTLY, SONY CONTACTED THE USER FACILITY THAT INITIATED THE REPORTED EVENT, BUT THEY HAD NO OTHER RECORDS OR REPORTS TO DOCUMENT THE REPORTED EVENT. THE PRINTER IN QUESTION WAS NO LONGER AVAILABLE FOR EXAMINATION TO DETERMINE IF THE REPORTED EVENT WAS A RESULT OF A PROBLEM WITH THE PRINTER OR A RESULT OF MIS-HANDLING AT THE USER FACILITY. THE EVENT WAS NOT OTHERWISE REPORTED TO SONY NOR WAS THE PRINTER IN QUESTION SENT TO ANY SONY FACILITY FOR REPAIR. AN INTERNAL REVIEW WAS MADE FOR ALL REPORTED COMPLAINTS AND REPAIRS ON THE UP51MD PRINTER, AND NO SIMILAR EVENTS HAVE BEEN REPORTED. IN LIGHT OF THE FACT THAT THERE WAS NO PATIENT INVOLVEMENT AND IN LIGHT OF THE LACK OF INFORMATION ABOUT THE PRINTER IN QUESTION, SONY CONCLUDES THAT, AS FAR AS ITS INVESTIGATION WAS ABLE TO DETERMINE, NO MDR INCIDENT HAS OCCURRED IN THIS CASE.