AMSCO
Received Nov 3, 2023 · Event occurred Oct 9, 2023
Report 3005899764-2023-00061 · MDR key 18064307
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 600 STEAM STERILIZERCatalog number
EF1101242
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM TWO OF THEIR AMSCO 600 STERILIZERS ONTO THE FLOOR. NO REPORT OF INJURY.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN INSPECTED THE AMSCO 600 STERILIZER'S 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. ADDITIONALLY, THE TECHNICIAN FOUND THAT THE SIGHT GLASS NUTS WERE LOOSE. THE DEVICE HISTORY RECORD FOR BOTH UNITS WERE REVIEWED AND CONFIRMED THEY WERE MANUFACTURED ACCORDING TO SPECIFICATIONS. THE TECHNICIAN REPLACED BOTH THE FLOATS AND SIGHT GLASS. THE UNIT WAS THEN TESTED, CONFIRMED TO OPERATING ACCORDING TO SPECIFICATION AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Additional Manufacturer Narrative
UDI RELATED DATA QUALITY UPDATES ONLY - ALIGNMENT WITH GUDID.