AMSCO
Received Oct 5, 2023 · Event occurred Sep 5, 2023
Report 3005899764-2023-00051 · MDR key 17879148
Device
Generic name
Amsco 600 Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 600 STEAM STERILIZERCatalog number
EF1201222
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 INSPECTED THE AMSCO 600 STERILIZER AND FOUND THAT THE FLOATS THAT CONTROL THE WATER PUMP WERE NOT OPERATING PROPERLY SUBSEQUENTLY CAUSING THE WATER PUMP TO CONTINUOUSLY RUN AND LEAK WATER. THE STERIS TECHNICIAN REPAIRED THE AMSCO 600 STERILIZER, TESTED THE UNIT AND CONFIRMED IT TO BE OPERATING PROPERLY. THE TECHNICIAN RETURNED THE AMSCO 600 STERILIZER TO SERVICE. A COMPLAINT REVIEW HAS DETERMINED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THEIR AMSCO 600 STERILIZER WAS LEAKING WATER OUT ONTO THE FLOOR. NO REPORT OF INJURY.
Additional Manufacturer Narrative
UDI RELATED DATA QUALITY UPDATES ONLY - ALIGNMENT WITH GUDID.