inforMED
MalfunctionMLR

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

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.