inforMED
InjuryFLE

LOADING CAR

Received Dec 22, 2023 · Event occurred Nov 17, 2023

Report 3013300766-2023-00002 · MDR key 18380764

Device

Generic name

Loading Car

Manufacturer

Remeda Ab

Product problems

  • Device Fell
  • Device Fell

Patient

Unknown

  • Bone Fracture(s)
  • Bone Fracture(s)

Narrative

Description of Event or Problem

THE USER FACILITY REPORTED THAT THE GUARD RAIL TO THEIR LOADING CAR DETACHED AND FELL ONTO AN EMPLOYEE'S FOOT RESULTING IN A BROKEN TOE. MEDICAL TREATMENT SOUGHT AND ADMINISTERED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE LOADING CAR AND FOUND THE UNIT TO BE OPERATING PROPERLY; NO REPAIRS WERE REQUIRED. PER DISCUSSION WITH USER FACILITY PERSONNEL, THE TECHNICIAN LEARNED THAT USER FACILITY PERSONNEL HAD REMOVED THE GUARD RAILS WHILE LOADING INSTRUMENTS FOR A PREVIOUS CYCLE. THE EMPLOYEE INCORRECTLY REINSTALLED THEIR GUARD RAIL TO THE LOADING CAR RESULTING IN THE REPORTED EVENT. THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THEIR LOADING CAR, SPECIFICALLY PROPERLY INSTALLING THE GUARD RAIL. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.