AMSCO
Received Nov 27, 2024 · Event occurred Oct 28, 2024
Report 3005899764-2024-00068 · MDR key 20795503
Device
Generic name
Amsco 600 Steam Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 600 STEAM STERILIZERCatalog number
EF130114200102
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 STEAM STERILIZER AND FOUND THE UNIT TO BE OPERATING PROPERLY. NO ISSUES WERE NOTED WITH THE FUNCTION OR OPERATION OF THE UNIT; THE REPORTED EVENT COULD NOT BE DUPLICATED. THE TECHNICIAN RETURNED THE UNIT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Additional Manufacturer Narrative
INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE USER FACILITY REPORTED THAT UPON OPENING THE DOOR OF THEIR AMSCO 600 STEAM STERILIZER, WATER LEAKED ONTO THE FLOOR. NO REPORT OF INJURY.