EVOLUTION TRANSFER CARRIAGE

Description of Event or Problem

THE USER FACILITY REPORTED WHILE THEY WERE UNLOADING THEIR TRANSFER CARRIAGE THAT THE FORWARD WHEELS ON THE CART UNLOCKED. NO REPORT OF INJURY.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE TRANSFER CARRIAGE AND FOUND IT TO BE OPERATING ACCORDING TO SPECIFICATIONS. UPON FURTHER DISCUSSION WITH USER FACILITY PERSONNEL, IT WAS DETERMINED THAT REPAIRS HAD ALREADY BEEN CONDUCTED BY THE USER FACILITY'S SERVICE TEAM. THE SPECIFIC DETAILS OF THE REPAIRS MADE WERE NOT DISCLOSED. THIS UNIT IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE EVOLUTION TRANSFER CARRIAGE OPERATOR MANUAL (PG. 3) STATES, "A THOROUGH PREVENTIVE MAINTENANCE PROGRAM IS ESSENTIAL TO SAFE AND PROPER UNIT OPERATION. THIS MANUAL CONTAINS MAINTENANCE SCHEDULES AND PROCEDURES WHICH SHOULD BE FOLLOWED FOR SATISFACTORY EQUIPMENT PERFORMANCE." THE TECHNICIAN COUNSELED THE USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE EVOLUTION TRANSFER CARRIAGE, INCLUDING PROPER MAINTENANCE ACTIVITIES AND PROPERLY ENGAGING THE TRANSFER CARRIAGE WITH THE DOCKING STATION. 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.