inforMED
MalfunctionFLE

EVOLUTION TRANSFER CARRIAGE

Received Dec 8, 2023 · Event occurred Nov 10, 2023

Report 3005899764-2023-00068 · MDR key 18291456

Device

Generic name

Transfer Carriage

Model number

AX083020003

Catalog number

AX083020003

Product problems

  • Device Tipped Over
  • Device Tipped Over

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE STERIS SERVICE TECHNICIAN REPLACED THE LOCKING MECHANISM, TESTED THE FUNCTION AND OPERATION OF THE TRANSFER CARRIAGE, AND RETURNED THE DEVICE TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE 66" EVOLUTION TRANSFER CARRIAGE AND FOUND THAT THE LOCKING MECHANISM WAS BENT. AS THE LOCKING MECHANISM WAS BENT, THIS MAY HAVE CAUSED THE TRANSFER CARRIAGE TO NOT PROPERLY ENGAGE WITH THE DOCKING STATION RESULTING IN THE REPORTED EVENT. THIS UNIT IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE EVOLUTION TRANSFER CARRIAGE, INCLUDING PROPER MAINTENANCE ACTIVITIES. THE CARRIAGE HAS BEEN REMOVED FROM SERVICE AND IS PENDING REPAIRS. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR 66" EVOLUTION TRANSFER CARRIAGE FELL TO THE FLOOR WHILE AN EMPLOYEE WAS UNLOADING THE STERILIZER. NO REPORT OF INJURY.