AMSCO EVOLUTION
Received Jul 18, 2024 · Event occurred Jun 18, 2024
Report 3005899764-2024-00031 · MDR key 19775347
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
HC-900Catalog number
UE04
Product problems
- Device Fell
- Device Fell
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY, INSPECTED THE AMSCO EVOLUTION STERILIZER AND FOUND THE UNIT TO BE OPERATING PROPERLY. THE TECHNICIAN WAS NOTIFIED BY THE USER FACILITY THAT THE BOLTS THAT ATTACH THE TOP PANEL TO THE STERILIZER WERE MISSING. AS THE BOLTS WERE MISSING, THE TOP PANEL WAS NOT PROPERLY SECURED SUBSEQUENTLY CAUSING THE PANEL TO FALL AND CONTACT THE EMPLOYEE. THE PANEL OF THE AMSCO EVOLUTION STERILIZER WAS RE-INSTALLED WITH THE BOLTS BY THE USER FACILITY. THE UNIT HAS BEEN RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THE TOP PANEL OF THEIR EVOLUTION STERILIZER FELL OFF THE UNIT ONTO AN EMPLOYEE. MEDICAL TREATMENT WAS SOUGHT, THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS ADMINISTERED.