inforMED
MalfunctionFLE

AMSCO

Received Mar 26, 2025 · Event occurred Feb 19, 2025

Report 3005899764-2025-00027 · MDR key 21700848

Device

Generic name

Sterilizer

Model number

36H

Catalog number

SR21

Product problems

  • Detachment of Device or Device Component
  • Detachment of Device or Device Component

Patient

NA · Unknown

  • Pain
  • Pain

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE STERILIZER AND FOUND THAT THE LOWER PANEL WAS NOT PROPERLY SECURED. UPON FURTHER INSPECTION, THE TECHNICIAN FOUND THAT THE LOWER PANEL BOLT HAD FALLEN OFF WHICH CAUSED THE LOWER PANEL TO BECOME LOOSE AND THE REPORTED EVENT TO OCCUR. PRIOR TO THE REPORTED EVENT, THE EMPLOYEE BUMPED INTO THE PANEL WITH A CASE CART WHICH MAY HAVE CONTRIBUTED TO THE DETACHED BOLT. TO RESOLVE THE ISSUE, THE TECHNICIAN REATTACHED THE BOLT, TESTED THE STERILIZER, CONFIRMED IT TO BE OPERATING TO SPECIFICATIONS, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THE LOWER PANEL ON THEIR AMSCO 400 STEAM STERILIZER FELL AND CONTACTED THE EMPLOYEE. THE EMPLOYEE HAD TO USE A FOOT BRACE AS A RESULT.