NA

Additional Manufacturer Narrative

INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR ATLAS TRANSFER CARRIAGES FELL TO THE FLOOR WHILE AN EMPLOYEE WAS UNLOADING THE STERILIZER. NO REPORT OF INJURY.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE LATCHING SYSTEM OF THE CARRIAGE WAS MISALIGNED, SUBSEQUENTLY CAUSING THE REPORTED EVENT. ADDITIONALLY, THE TECHNICIAN DETERMINED THAT BOTH THE TRANSFER CARRIAGE AND DOCKING STATION WERE DAMAGED REQUIRING REPLACEMENT. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE TRANSFER CARRIAGE AND DOCKING STATION. THE TRANSFER CARRIAGE IS NOT UNDER A STERIS SERVICE CONTRACT 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 WITH THE DOCKING STATION. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR EVOLUTION TRANSFER CARRIAGE FELL TO THE FLOOR WHILE AN EMPLOYEE WAS UNLOADING THE STERILIZER. NO REPORT OF INJURY.