inforMED
MalfunctionFLE

ATLAS

Received Nov 28, 2025 · Event occurred Oct 24, 2025

Report 3005899764-2025-00095 · MDR key 23672051

Device

Generic name

Atlas Loading Car

Model number

AX015013081

Catalog number

AX015013081

Product problems

  • Use of Device Problem
  • Use of Device Problem

Patient

NA · Unknown

  • Pain
  • Pain

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE LOADING CAR AND TRANSFER CARRIAGE. THE TECHNICIAN FOUND NO ISSUES WITH THE FUNCTION OR OPERATION OF THE LOADING CAR AND TRANSFER CARRIAGE AND CONFIRMED THEM TO BE OPERATING TO SPECIFICATIONS. DURING FOLLOW-UP WITH USER FACILITY PERSONNEL, IT WAS CONFIRMED THAT THE EMPLOYEE DID NOT PROPERLY LATCH THE LOADING CAR TO THE TRANSFER CARRIAGE SUBSEQUENTLY CAUSING THE LOADING CAR TO BECOME UNSTABLE DURING UNLOADING, LEADING TO THE REPORTED EVENT. THE TECHNICIAN PERFORMED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE LOADING CAR SPECIFICALLY, THE IMPORTANCE OF ENSURING THE LOADING CAR IS PROPERLY LATCHED TO THE TRANSFER CARRIAGE. THE OPERATOR MANUAL STATES (PG. 3-1), "ALWAYS POSITIVELY LATCH LOADING CAR TO TRANSFER CARRIAGE WHEN CAR IS OUTSIDE STERILIZER." THE TECHNICIAN RETURNED THE LOADING CAR AND TRANSFER CARRIAGE TO SERVICE, AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE INJURED THEIR SHOULDER WHILE ATTEMPTING TO LIFT THE LOADING CAR TO THEIR ATLAS TRANSFER CARRIAGE. THE EMPLOYEE WENT TO THE FACILITY'S EMERGENCY ROOM; HOWEVER, IT IS UNKNOWN WHAT TREATMENT MAY HAVE BEEN ADMINISTERED.