inforMED
MalfunctionFLE

NA

Received Sep 4, 2025 · Event occurred Aug 7, 2025

Report 3005899764-2025-00073 · MDR key 22974397

Device

Generic name

Evolution 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

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT AND LEARNED WHILE USER FACILITY PERSONNEL WERE TURNING THE EVOLUTION TRANSFER CARRIAGE THE FRONT LEG ASSEMBLY SLID TOWARDS THE HANDLE, SUBSEQUENTLY CAUSING THE REPORTED EVENT. THE TECHNICIAN INSPECTED THE CARRIAGE AND FOUND THE FRONT LEG ASSEMBLY REQUIRED ADJUSTMENTS DUE TO A LACK OF PREVENTIVE MAINTENANCE BY USER FACILITY PERSONNEL. THE UNIT IS NOT UNDER STERIS SERVICE AGREEMENT FOR PREVENTIVE MAINTENANCE ACTIVITIES; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE EVOLUTION TRANSFER CARRIAGE OPERATOR MANUAL STATES, "A THOROUGH PREVENTIVE MAINTENANCE PROGRAM IS ESSENTIAL TO SAFE AND PROPER UNIT OPERATION. THIS MANUAL CONTAINS MAINTENANCE SCHEDULES AND PROCEDURES WHICH SHOULD BE FOLLOWED FOR SATISFACTORY EQUIPMENT PERFORMANCE." TO RESOLVE THE ISSUE, THE TECHNICIAN WILL REPLACE THE FRONT LEG ASSEMBLY AND PROVIDE COUNSELING TO USER FACILITY PERSONNEL ON THE PROPER PREVENTIVE MAINTENANCE OF THE EVOLUTION TRANSFER CARRIAGE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THEIR EVOLUTION TRANSFER CARRIAGE "FELL DOWN" WHILE TRANSPORTING A LOAD. NO REPORT OF INJURY.

Additional Manufacturer Narrative

THE TECHNICIAN REPLACED THE FRONT LEG ASSEMBLY TO THE EVOLUTION TRANSFER CARRIAGE. THE CARRIAGE WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. WHILE ONSITE, THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER PREVENTIVE MAINTENANCE PRACTICES FOR THE EVOLUTION TRANSFER CARRIAGE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.