V-PRO MAX STERILIZER

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A CYCLE, THEIR V-PRO MAX STERILIZER CAUGHT FIRE. THE FIRE WAS EXTINGUISHED BY THE FIRE DEPARTMENT. NO REPORT OF INJURY.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE V-PRO MAX STERILIZER AND OBSERVED DAMAGE BELOW THE UNIT NEAR THE AIR COMPRESSOR. HOWEVER, DUE TO THE DAMAGE SUSTAINED, THE TECHNICIAN WAS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. FOLLOWING THE TECHNICIAN'S INSPECTION, THE USER FACILITY DISCARDED THE UNIT. WITHOUT RETURN OF THE V-PRO MAX STERILIZER TO STERIS FOR FURTHER EVALUATION, THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE USER FACILITY ORDERED A REPLACEMENT UNIT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE, THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.

Additional Manufacturer Narrative

CONTRARY TO THE INITIAL MDR, THE UNIT WAS LOCATED AND RETURNED TO STERIS R&D FOR EVALUATION. THE EVALUATION CONFIRMED THE TECHNICIAN'S INSPECTION RESULTS THAT THE DAMAGE WAS AT THE BOTTOM OF THE UNIT NEAR THE AIR COMPRESSOR. DUE TO THE DAMAGE SUSTAINED, STERIS R&D WAS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. THE UNIT WAS INSTALLED IN 2015 MAKING IT APPROXIMATELY 10 YEARS OLD. THE V-PRO MAX STERILIZER IS DESIGNED WITH FLAME-RESISTANT MATERIALS AND IS CERTIFIED BY INTERTEK TO UL 61010-1:2012 3RD ED./CSA C22.2#61010-1-12:2012, 3RD ED. SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE, PART 1, AND UL 61010-2-040:2021, 3RD ED/CSA C22.2#61010-2-040:2021 3RD ED., SAFETY REQUIREMENTS, PART 2-040 - PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS. A THERMAL EVENT WOULD NOT BE EXPECTED TO SPREAD DUE TO THE FLAME-RESISTANCE OF THE SURROUNDING MATERIALS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.