inforMED
MalfunctionFLE

AMSCO

Received Sep 25, 2024 · Event occurred Aug 26, 2024

Report 3005899764-2024-00049 · MDR key 20304721

Device

Generic name

Sterilizer

Catalog number

SR0201210311

Product problems

  • Leak/Splash
  • Leak/Splash

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE WATER MANIFOLD BOLT WAS DAMAGED, CAUSING THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE BOLT. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED TO SERVICE. WHILE ONSITE, THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER REGULATION OF THE WATER PRESSURE FOR THE AMSCO 400 STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED A WATER LEAK ONTO THE FLOOR FROM THEIR AMSCO 400 STERILIZER. NO REPORT OF INJURY.