inforMED
MalfunctionFLE

NA

Received Dec 31, 2024 · Event occurred Dec 4, 2024

Report 3005899764-2024-00079 · MDR key 21048761

Device

Generic name

Evolution Transfer Carriage

Model number

AX082020003

Catalog number

AX082020003

Product problems

  • Misassembly During Maintenance/Repair
  • Misassembly During Maintenance/Repair

Patient

NA · Unknown

  • Bruise/Contusion
  • Bruise/Contusion

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE CART REQUIRED ADJUSTMENT. THIS CAUSED THE CART TO NOT LOCK IN PLACE CORRECTLY, SUBSEQUENTLY CAUSING THE REPORTED EVENT. WHILE ONSITE, THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER MAINTENANCE OF THE EVOLUTION TRANSFER CARTILAGE. THE TECHNICIAN ORDERED REPLACEMENT PARTS TO PERFORM THE NECESSARY REPAIRS. THE CART HAS BEEN REMOVED FROM SERVICE PENDING REPAIRS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE REPAIRS ARE COMPLETED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BRUISE ON THEIR HAND AFTER A LOADING RACK FELL FROM THEIR EVOLUTION TRANSFER CARRIAGE. THE EMPLOYEE SOUGHT MEDICAL TREATMENT AND RECEIVED A BANDAGE.

Additional Manufacturer Narrative

TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE FRONT LEG CASTER ASSEMBLY OF THE TRANSFER CART. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.