48" PLATFORM PREVAC STERILIZER
Received Nov 9, 2023 · Event occurred Oct 11, 2023
Report 3005899764-2023-00063 · MDR key 18103758
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
UDI RELATED DATA CLARIFICATION - THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE, THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN INSPECTED THE 48" PLATFORM STERILIZER AND FOUND THE DOOR LOCK CYLINDER TO BE DAMAGED. THE STERIS TECHNICIAN STATED THAT THE DAMAGED DOOR LOCK CYLINDER CAUSED STEAM TO LEAK FROM THE UNIT SUBSEQUENTLY CAUSING CONDENSATION TO BUILD UP ON THE FLOOR. THE STERIS TECHNICIAN REPLACED THE DOOR LOCK CYLINDER, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING PROPERLY AND RETURNED IT TO SERVICE. THE 48" PLATFORM STERILIZER IS NOT UNDER A STERIS SERVICE CONTRACT. THE USER FACILITY IS RESPONSIBLE FOR SERVICE AND MAINTENANCE. THE UNIT WAS INSTALLED IN 2009 AND HAS BEEN IN USE FOR APPROXIMATELY 14 YEARS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE SLIPPED AND FELL ON WATER LOCATED IN FRONT OF THE 48" PLATFORM STERILIZER. THE EMPLOYEE WAS SENT TO URGENT CARE. IT IS UNKNOWN IF THE EMPLOYEE RECEIVED MEDICAL TREATMENT.