MalfunctionFLE

AMSCO 600 STERILIZER

Received Jun 13, 2024 · Event occurred May 15, 2024

Report 3005899764-2024-00026 · MDR key 19534380

Device

Generic name

Sterilizer

Manufacturer

Steris Mexico, S. De R.l. De C.v.

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 THEIR AMSCO 600 STERILIZER. NO REPORT OF INJURY.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE STERILIZER AND FOUND THE MAIN WATER FEED LINE TO THE VACUUM PUMP SEPARATED AT THE CRIMP FITTING. AFTER FURTHER INSPECTION, THE TECHNICIAN FOUND THE CRIMP WAS DAMAGED. THE TECHNICIAN REPLACED THE HOSE, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.