V-PRO MAX 2 ENGLISH DD REC 400V 50/60HZ
Received Aug 9, 2024 · Event occurred Jul 9, 2024
Report 3005899764-2024-00036 · MDR key 19950389
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
MAX 2Catalog number
VP50003201
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Headache
- Headache
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE V-PRO MAX 2 STERILIZER AND FOUND THE UNIT TO BE OPERATING PROPERLY. NO ISSUES WITH THE FUNCTION OR OPERATION OF THE STERILIZER WERE IDENTIFIED. NO REPAIRS WERE REQUIRED, AND THE UNIT WAS RETURNED TO SERVICE. WHILE ONSITE, THE TECHNICIAN LEARNED THAT THE EMPLOYEE EXPERIENCED A HEADACHE ONE DAY AFTER THE REPORTED EVENT. THE TECHNICIAN LEARNED THIS IS THE FACILITY'S ONLY STERILIZER. IT HAS BEEN IN USE SINCE MARCH 2024. BASED ON THE TECHNICIAN'S INSPECTION AND DISCUSSION WITH USER FACILITY PERSONNEL, AN EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE STERIS SERVICE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE STERILIZER AND CORRECT PROTOCOLS ONCE THE CYCLE HAS COMPLETED. A 3-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED A HEADACHE AFTER UNLOADING A V-PRO MAX 2 STERILIZER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT AND WAS ADMINISTERED PARACETAMOL.