MalfunctionFLE
RENAISSANCE STERILIZER
Received Apr 18, 2024 · Event occurred Mar 18, 2024
Report 3005899764-2024-00016 · MDR key 19130397
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 STEAM WAS LEAKING FROM THEIR RENAISSANCE STERILIZER AND SET OFF THE FIRE ALARM. NO REPORT OF INJURY.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE PRESSURE REGULATING VALVE HAD FAILED WHICH CAUSED THE REPORTED EVENT. THE TECHNICIAN REBUILT THE PRESSURE REGULATING VALVE. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.