AMSCO
Received Aug 19, 2025 · Event occurred Jul 21, 2025
Report 3005899764-2025-00070 · MDR key 22841918
Device
Generic name
Amsco 600 Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 600 STEAM STERILIZERCatalog number
EF1301110
Product problems
- Display or Visual Feedback Problem
- Display or Visual Feedback Problem
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 THEIR AMSCO 600 STERILIZER HAS HAD INTERMITTENT ISSUES RESULTING IN PROCEDURE CANCELLATIONS. NO REPORT OF INJURY.
Additional Manufacturer Narrative
OUR INVESTIGATION INTO THE REPORTED EVENT IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ON-SITE TO INSPECT THE AMSCO 600 STERILIZER AND FOUND THAT THE UNIT'S AIR PRESSURE WAS BELOW THE SPECIFIED LIMIT, AND THAT THE DOOR PROXIMITY SWITCHES AND DOOR PRESSURE SET POINTS REQUIRED ADJUSTMENT. THE TECHNICIAN INSTALLED AN AIR FILTER FOR THE STERILIZER AND MADE THE NECESSARY DOOR ASSEMBLY ADJUSTMENTS, CONFIRMED THE UNIT TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED IT TO SERVICE. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THE UNIT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. A 3-YEAR COMPLAINT REVIEW DETERMINED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.