V-PRO
Received Mar 6, 2025 · Event occurred Feb 4, 2025
Report 3005899764-2025-00023 · MDR key 21536552
Device
Generic name
V-pro Max 2 Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
MAX 2Catalog number
VP50002101
Product problems
- Gas/Air Leak
- Gas/Air Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE V-PRO MAX 2 STERILIZER AND FOUND THAT THE UNIT'S VACUUM PUMP WAS LEAKING OIL AND REQUIRED REPLACEMENT. AS A RESULT OF THE OIL LEAK, THE UNIT LIKELY EMITTED AN OIL MIST, NOT SMOKE. THE VACUUM PUMP OIL IS NON-TOXIC AND NOT CONSIDERED HAZARDOUS. THE TECHNICIAN REPLACED THE VACUUM PUMP, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THEIR V-PRO MAX 2 STERILIZER WAS EMITTING "SMOKE" AND LEAKING OIL ONTO THE FLOOR. NO REPORT OF INJURY.