NA

Additional Manufacturer Narrative

THE USER FACILITY'S BIOMED INSPECTED AND PERFORMED THE NECESSARY REPAIRS TO THE EVOLUTION TRANSFER CARRIAGE PRIOR TO THE STERIS TECHNICIAN'S ARRIVAL. THE USER FACILITY STATED THAT THE TRANSFER CARRIAGE AND STERILIZER WERE NOT ALIGNED PROPERLY WHICH RESULTED IN THE TRANSFER CARRIAGE NOT REMAINING ENGAGED. THE STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE BIOMED'S REPAIRS TO INSPECT THE EVOLUTION TRANSFER CARRIAGE AND FOUND IT TO BE OPERATING ACCORDING TO SPECIFICATIONS. THIS UNIT IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. 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 TO THE STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS UNLOADING THEIR STERILIZER, THE EVOLUTION TRANSFER CARRIAGE BECAME UNSTABLE AND FELL TO THE FLOOR. THE EMPLOYEE OBTAINED "WHIPLASH" BUT DID NOT SEEK IMMEDIATE MEDICAL TREATMENT WITHIN THE EMERGENCY DEPARTMENT. THE EMPLOYEE DID RECEIVE PHYSICAL THERAPY FOLLOWING THE REPORTED EVENT.