inforMED
MalfunctionFLE

TRANSFER CARRIAGE

Received Feb 5, 2025 · Event occurred Jan 2, 2025

Report 3005899764-2025-00009 · MDR key 21315611

Device

Generic name

Transfer Carriage

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Muscle/Tendon Damage
  • Muscle/Tendon Damage

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT ALL THE UNITS AT THE USER FACILITY AND FOUND THEM TO BE FUNCTIONING PROPERLY. ALL UNITS WERE TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. ADDITIONALLY, THE TECHNICIAN WAS INFORMED THAT WHEN THE CARRIAGE DID NOT RELEASE RIGHT AWAY FROM THE DOCKING STATION, THE EMPLOYEE ATTEMPTED TO PULL THE CARRIAGE, SUBSEQUENTLY CAUSING THE REPORTED INJURY. THE EVOLUTION TRANSFER CARRIAGE IFU STATES, "GET HELP IF LOADING CAR BECOMES STUCK OR DIFFICULT TO MOVE. DO NOT ATTEMPT TO LIFT A LOADING CAR WITHOUT ASSISTANCE." USER FACILITY PERSONNEL WERE COUNSELED ON THE PROPER USE AND OPERATION OF THE EVOLUTION TRANSFER CARRIAGE. THE USER FACILITY WAS UNABLE TO IDENTIFY THE SERIAL NUMBER OF THE CARRIAGE INVOLVED IN THE REPORTED EVENT. UDI RELATED DATA - THE LOT/SERIAL NUMBER IS UNKNOWN; THEREFORE, THE APPLICABLE PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE STRAINED THEIR SHOULDER WHILE UNLOADING AN EVOLUTION TRANSFER CARRIAGE. THE EMPLOYEE RECEIVED MEDICAL TREATMENT; HOWEVER, IT IS UNKNOWN WHAT TYPE OF MEDICAL TREATMENT WAS ADMINISTERED.