inforMED
MalfunctionFLE

AMSCO

Received Mar 7, 2025 · Event occurred Feb 10, 2025

Report 3005899764-2025-00024 · MDR key 21549415

Device

Generic name

Amsco 600 Steam Sterilizer

Catalog number

EF1101140

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 ON SITE THE STERILIZER AND FOUND THAT THE UTILITIES ON THE STERILIZER WERE TURNED OFF. UPON FURTHER INSPECTION, THE TECHNICIAN IDENTIFIED A HOLE IN THE DRAINPIPE HOSE CONNECTED TO THE UNIT, WHICH WAS CAUSING WATER TO LEAK FROM THE STERILIZER AND LED TO THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE HOSE, 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 THEIR AMSCO 600 STERILIZER WAS LEAKING WATER ONTO THE FLOOR. NO REPORT OF INJURY.