inforMED
MalfunctionFLE

EVOLUTION TRANSFER CARRIAGE

Received Sep 16, 2022 · Event occurred Aug 18, 2022

Report 3005899764-2022-00043 · MDR key 15439605

Device

Generic name

Transfer Carriage

Model number

AX083020003

Catalog number

AX083020003

Product problems

  • Device Tipped Over
  • Device Tipped Over

Patient

Unknown

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

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE TRANSFER CARRIAGE AND FOUND THAT THE LEFT LEG LOCK OF THE TRANSFER CARRIAGE WAS OUT OF ADJUSTMENT PREVENTING THE TRANSFER CARRIAGE TO PROPERLY LOCK TO THE DOCKING STATION. THE EVOLUTION TRANSFER CARRIAGE IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE EVOLUTION TRANSFER CARRIAGE OPERATOR MANUAL STATES (1-1), WARNING - PERSONAL INJURY HAZARD: REPAIRS AND ADJUSTMENTS, OTHER THAN THOSE DESCRIBED IN THESE INSTRUCTIONS, SHOULD BE ATTEMPTED ONLY BY EXPERIENCED MECHANICS FULLY ACQUAINTED WITH THIS EQUIPMENT. USE OF INEXPERIENCED, UNQUALIFIED PERSONS TO WORK ON THE EQUIPMENT OR THE INSTALLATION OF UNAUTHORIZED PARTS COULD CAUSE PERSONAL INJURY OR RESULT IN COSTLY DAMAGE. THE TECHNICIAN COUNSELED FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE TRANSFER CARRIAGE AND DOCKING STATION, SPECIFICALLY ON PROPER PREVENTIVE MAINTENANCE. THE TECHNICIAN MADE THE NECESSARY REPAIRS, TESTED THE UNIT, CONFIRMED IT WAS OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS UNLOADING THEIR EVOLUTION TRANSFER CARRIAGE, IT FELL TO THE FLOOR CONTACTING THEIR FOOT. THE EMPLOYEE RECEIVED X-RAYS.