inforMED
MalfunctionFLE

ATLAS

Received Nov 21, 2025 · Event occurred Oct 17, 2025

Report 3005899764-2025-00090 · MDR key 23621683

Device

Generic name

Transfer Cariage

Model number

AX0660230830000013

Catalog number

AX0660230830000013

Product problems

  • Use of Device Problem
  • Use of Device Problem

Patient

NA · Unknown

  • Burn(s)
  • Burn(s)

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT AND FOUND THAT THE CATCH ROD OF THE LATCHING SYSTEM WAS DAMAGED DUE TO IMPROPER MAINTENANCE BY USER FACILITY PERSONNEL. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE CATCH ROD OF THE LATCHING SYSTEM. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. THE UNIT IS NOT UNDER STERIS SERVICE AGREEMENT FOR PREVENTIVE MAINTENANCE ACTIVITIES; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. WHILE ONSITE THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER MAINTENANCE OF THE ATLAS TRANSFER CARRIAGE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR ARM AFTER STRUGGLING TO UNLATCH THE ATLAS TRANSFER CARRIAGE FROM THEIR STERILIZER. THE EMPLOYEE RECEIVED BURN CREAM AND A BANDAGE AND RETURNED TO WORK.