AMSCO
Received Mar 7, 2025 · Event occurred Feb 10, 2025
Report 3005899764-2025-00024 · MDR key 21549415
Device
Generic name
Amsco 600 Steam Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 600 STEAM STERILIZERCatalog 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.