STERRAD® 100NX STERILIZER 1-DR

Additional Manufacturer Narrative

E1. INITIAL REPORTER PHONE NUMBER: (B)(6). A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. THE VACUUM PUMP AND TRAY ASSEMBLY WERE REPLACED TO RESOLVE THE MIST/HAZE AND ODOR/SMELLS ISSUES. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE. H3: ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), TRENDING ANALYSIS OF THE MIST/HAZE AND ODOR/SMELLS ISSUE, AND SYSTEM RISK ANALYSIS (SRA). THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ISSUES RELATING TO THE FAILURE MODE WERE NOTED. THE INVOLVED UNIT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. TRENDING ANALYSIS OF THE MIST/HAZE AND ODOR/SMELLS ISSUES FOR THE STERRAD® 100NX UNIT WAS REVIEWED FOR THE PRIOR SIX MONTHS FROM THE EVENT DATE, AND NO SIGNIFICANT TREND WAS OBSERVED. REVIEW OF RISK DOCUMENTATION SHOWS THE RISK FOR EXPOSURE TO TOXIC OR CORROSIVE MATERIAL TO BE "LOW." NO PARTS WERE AVAILABLE FOR FURTHER ANALYSIS. THE ASSIGNABLE CAUSE OF THE MIST/HAZE AND ODOR/SMELL IS LIKELY DUE TO THE VACUUM PUMP AND TRAY ASSEMBLY. THE ASP FIELD SERVICE ENGINEER REPLACED THE PARTS AND CONFIRMED THE STERRAD® 100NX MET FUNCTIONAL SPECIFICATIONS AFTER SERVICE. THE ISSUE WAS RESOLVED AT THE CUSTOMER FACILITY. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ADVANCED STERILIZATION PRODUCTS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ADVANCED STERILIZATION PRODUCTS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ASP COMPLAINT REF #: (B)(4).

Description of Event or Problem

A CUSTOMER REPORTED AN EVENT OF A ¿MIST¿ OR HAZE AND A ¿BURNING ODOR¿ OR SMELL EMITTING FROM THE STERRAD® 100NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.