700-SERIES

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF ISSUE WITH TRANSFER TROLLEY USED WITH 733HC-E STERILIZER. AS IT WAS STATED BY THE TECHNICIAN, THE CUSTOMER COMPLAINED THAT WHEN THE CART IS ON A TROLLEY WHICH IS NOT HOOKED UP TO THE STERILIZER, THE CART CAN JUMP OUT OF THE WHEEL TRACK. THE CUSTOMER STATED THAT DUE TO THIS SITUATION ITEMS FELL AND CAUSED AN INJURY. OPERATOR BROKE HIS TOE. IT WAS DECIDED TO REPORT THE ISSUE BASED ON THE INFORMATION AS THIS SITUATION LED TO SERIOUS INJURY. DURING THE VISIT, GETINGE TECHNICIANS HAVE PERFORMED ADJUSTMENT OF LOCKING MECHANISM OF THE TROLLEY AND THEY LEVELED TROLLEY CASTER. TROLLEY WAS TESTED AND CONFIRMED TO BE FULLY FUNCTIONAL. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE ABLE TO ESTABLISH THAT THE RECEIVED INCIDENT IS THE FIFTH REGISTERED IN GETINGE CUSTOMER PRODUCT COMPLAINT HANDLING SYSTEMS RELATED TO CART FALL/SLIDE FROM TROLLEY ON 700-SERIES HEALTHCARE STERILIZERS. HOWEVER FORMER CUSTOMER PRODUCT COMPLAINTS WERE RELATED TO LATCHING MECHANISM AND USER ERROR THAT IN INVESTIGATED COMPLAINT WORKS AS INTENDED. THE INVESTIGATED EVENT HAS LED TO SERIOUS INJURY. WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION BECAUSE THE TROLLEY WAS OUT OF ADJUSTMENT AND CONTRIBUTED TO THE EVENT. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT WHEN THE EVENT TOOK PLACE. DESPITE MULTIPLE ATTEMPTS FROM GETINGE TECHNICIANS, IT WAS IMPOSSIBLE TO RECEIVE INFORMATION ABOUT COURSE OF EVENT AND ITEMS/LOADS THAT WERE STERILIZED THAT WOULD HELP MANUFACTURER TO EVALUATE THE SITUATION MORE PRECISELY. BASED ON THE PERFORMED ROOT CAUSE ANALYSIS WE CONCLUDE THAT THE FINAL ROOT CAUSE DUE TO MISSING INFORMATION FROM CUSTOMER WAS IMPOSSIBLE TO DEFINE. THE MOST PROBABLE CONTRIBUTING FACTOR IS CONNECTED TO CUSTOMER ERROR. PER REQUIREMENTS OF ANSI/AAMI ST79:2017, POINT 4.5.1 OPERATOR SHOULD WEAR SHOES STURDY ENOUGH TO PREVENT INJURY IF AN ITEM DROPS ON THE FOOT. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICES, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION.

Description of Event or Problem

MANUFACTURER REFERENCE NUMBER (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON (B)(6) 2021 GETINGE BECAME AWARE OF ISSUE WITH TRANSFER TROLLEY USED WITH 733HC-E STERILIZER. AS IT WAS STATED BY THE TECHNICIAN CUSTOMER COMPLAINED THAT WHEN CART IS ON THE TROLLEY AND THE TROLLEY IS NOT HOOKED TO THE STERILIZER, THE CART CAN JUMP OUT OF THE WHEEL TRACK. CUSTOMER STATED THAT DUE TO THIS SITUATION ITEMS FELT AND CAUSED AN INJURY. OPERATOR BROKE HIS TOE. WE DECIDED TO REPORT THE ISSUE BASED ON THE INFORMATION AS SUCH SITUATION LEAD TO SERIOUS INJURY. DURING THE VISIT, GETINGE TECHNICIANS HAVE PERFORMED ADJUSTMENT OF LOCKING MECHANISM OF THE TROLLEY AND THEY LEVELED TROLLEY CASTER. TROLLEY WAS TESTED AND CONFIRMED TO BE FULLY FUNCTIONAL.