V-PRO MAX 2 STERILIZER
Received Jan 11, 2024 · Event occurred Dec 12, 2023
Report 3005899764-2024-00003 · MDR key 18500054
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Leak/Splash
- Leak/Splash
Patient
Unknown
- Headache
- Headache
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT 8 EMPLOYEES EXPERIENCED HEADACHES WHILE A CYCLE WAS IN PROCESS FOR THEIR V-PRO MAX 2 STERILIZER. THE EMPLOYEES WERE SENT TO THE FACILITY'S ER. NO MEDICAL TREATMENT WAS ADMINISTERED, AND ALL EMPLOYEES RETURNED TO WORK.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN INSPECTED THE V-PRO MAX 2 STERILIZER AND FOUND THE AIR MIST ELIMINATOR TO BE SATURATED WITH OIL. THE TECHNICIAN FURTHER INSPECTED THE UNIT AND FOUND THE UMBRELLA CHECK VALVE WAS DISLODGED SUBSEQUENTLY ALLOWING THE FILTERS IN THE AIR MIST ELIMINATOR TO BECOME SATURATED WITH OIL. THE VACUUM PUMP OIL IS NON-TOXIC AND NOT CONSIDERED HAZARDOUS. THE STERIS TECHNICIAN REPLACED THE FILTERS WITHIN THE AIR MIST ELIMINATOR, THE O-RINGS AND UMBRELLA CHECK VALVE AND OIL IN THE UNIT'S RESERVOIR. THE TECHNICIAN RAN A TEST CYCLE, CONFIRMED THE UNIT TO BE OPERATING TO SPECIFICATIONS AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.