Description of Event or Problem · 1
THE DOOR THRUST BEARING FAILED BECAUSE EXCESSIVE FORCE WAS APPLIED DURING PERVIOUS OPERATION OF CLOSING THE CHAMBER DOOR. THIS CAUSES A THRUST BALL BEARING TO FAIL. THE MFR'S INVESTIGATION REPORT FURTHER INDICATES THAT IF THE FACTORY INSTRUCTIONS FOR CLOSING THE DOOR ARE FOLLOWED, THERE WILL BE NO PROBLEM. THE MFR'S INVESTIGATION REPORT STATES "DESPITE THE FACT THAT NO ACTUAL DANGER EXISTS AS THE DOOR WILL ONLY OPEN 3 MM (1/8") AS THE RESULT OF A BROKEN BEARING. A NOISE WILL BE HEARD WHEN THE BEARING BURST AND THE DOOR HANDLE MECHANISM WILL REQUIRE REPLACEMENT, BUT NO OTHER DAMAGE WILL OCCUR." THE MFR STATES THAT THEY HAVE THOUSANDS OF THESE UNITS OPERATING WORLDWIDE AND ONLY 3 COMPLAINTS. THE MFR HAS REPLACED THE BALL BEARING WITH A SOLID MATERIAL THRUST BEARING ON ALL STERILIZERS SHIPPED SINCE 12/18/94. THEY WILL NOT EFFECT A BLANKET RECALL OF ALL MODEL SERIES 2540 UTILIZING THE BALL BEARING. THE MFR HAS SHIPPED 6 NEW REPLACEMENT DOOR CLOSURE DEVICES TO THE COMPLAINANT. THE FINAL SUMMARY OF THE FACTORY INVESTIGATION STATES "THE BEARINGS ON CUSTOMER UNITS WILL BE REPLACED AS PER DEALER DISCRETION." MFR HAS REDESIGNED THE BEARING. USERS OF THIS MODEL THAT EXPERIENCE A DOOR BEARING PROBLEM SHOULD SEND A REPORTING AND PROCESSING MEDICAL MATERIAL COMPLAINTS/QUALITY IMPROVEMENT REPORT, FORM 380, REFERENCING THIS PROJECT. THIS PROJECT IS CLOSED PENDING NEW COMPLAINTS OF THE SAME NATURE. CURRENT COMPLAINANT RECEIVED NEW REPLACEMENT PARTS. POSSIBLE FUTURE COMPLAINANTS WILL BE HANDLED ON A CASE BY CASE BASIS.