inforMED
MalfunctionFLE

EVOLUTION TRANSFER CARRIAGE

Received Feb 9, 2024 · Event occurred Jan 11, 2024

Report 3005899764-2024-00006 · MDR key 18676806

Device

Generic name

Transfer Carriage

Product problems

  • Device Tipped Over
  • Device Tipped Over

Patient

NA · Unknown

  • Pain
  • Pain

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE EVOLUTION TRANSFER CARRIAGE AND FOUND THAT THE DOCKING PLATE WHERE THE TRANSFER CARRIAGE ENGAGES WAS DAMAGED. IT IS UNKNOWN IF THIS DAMAGE WAS PRESENT PRIOR TO THE REPORTED EVENT OR CAUSED BY THE FALLING TRANSFER CARRIAGE. ADDITIONALLY, THE TECHNICIAN FOUND THAT THE USER FACILITY HAD ATTACHED ZIP TIES NEAR THE LOCKING PIN ON THE TRANSFER CARRIAGE. THE LOCKING PIN IS INTENDED TO HOLD THE FRONT LEGS OF THE TRANSFER CARRIAGE TO THE DOCKING STATION WHILE UNLOADING THE STERILIZER. IF THE PIN WAS NOT FULLY ENGAGED DUE TO THE ZIP TIES, THEN THIS MAY HAVE RESULTED IN THE REPORTED EVENT. THE UNIT IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE TECHNICIAN REPLACED THE DOCKING PLATE AND REMOVED THE CUSTOMER'S ZIP TIES FROM THE TRANSFER CARRIAGE. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED TO SERVICE. THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE EVOLUTION TRANSFER CARRIAGE, INCLUDING PROPER MAINTENANCE ACTIVITIES. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR EVOLUTION TRANSFER CARRIAGE FELL FORWARD WHILE AN EMPLOYEE WAS UNLOADING THEIR STERILIZER RESULTING IN SHOULDER PAIN. THE EMPLOYEE SOUGHT MEDICAL TREATMENT AND RECEIVED AN X-RAY. THE EMPLOYEE HAS RETURNED TO WORK.