48" PLATFORM PREVAC STERILIZER
Received Jan 29, 2025 · Event occurred Dec 22, 2024
Report 3005899764-2025-00008 · MDR key 21264680
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Mechanical Problem
- Mechanical Problem
Patient
NA · Unknown
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT AND FOUND THAT THE DOOR HINGES WERE WORN AND MISALIGNED. THE TECHNICIAN OBSERVED THAT WHEN THE DOOR WOULD OPEN IT WOULD CONTACT THE BOTTOM EDGE OF THE DOOR FRAME, MAKING IT MORE DIFFICULT TO OPEN. THE 48" PLATFORM PREVAC STERILIZER IS NOT UNDER A STERIS SERVICE CONTRACT FOR MAINTENANCE ACTIVITIES; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE TECHNICIAN ADJUSTED THE DOOR AND PROVIDED A REPLACEMENT QUOTE TO THE USER FACILITY TO REPLACE THE DOOR HINGES. THE 48" PLATFORM PREVAC STERILIZER WAS RETURNED TO SERVICE. 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.
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE SPRAINED THEIR WRIST WHILE OPENING THE DOOR TO THEIR 48" PLATFORM PREVAC STERILIZER. THE EMPLOYEE WAS GIVEN OVER-THE-COUNTER PAIN RELIEVER.