800-SERIES

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF INCIDENT WITH THE 833HC-E STERILIZER. AS IT WAS STATED BY THE GETINGE TECHNICIAN, STAFF GOT BACK INJURED WHILE REMOVING A LOADED CART FROM THE STERILIZER AS THE CART GOT CAUGHT. NO DETAILED INFORMATION REGARDING THE INJURY WAS RECEIVED. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS THE DESCRIBED EVENT COULD LEAD TO SERIOUS INJURY. GETINGE SERVICE TECHNICIAN PERFORMED THE REPLACEMENT OF STIFF ROLLERS THAT COULD CAUSE RESISTANCE TO CART WHEN REMOVING FROM CHAMBER. ALL ROLLERS WERE CHECKED, AND DEVICE WAS RETURNED TO SERVICE. GETINGE SERVICE TECHNICIAN ALSO INFORM THAT GETINGE CARTS THAT ARE USED DO NOT HAVE ORIGINAL WHEELS. WHEELS HAVE BEEN REPLACED BY THE BIOMED AT THE HOSPITAL AND THEY ARE NOT FROM GETINGE. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUE FOR 833HC-E WE WERE ABLE TO ESTABLISH THAT THE RECEIVED INCIDENT IS THE SECOND ONE REGISTERED IN GETINGE COMPLAINT HANDLING SYSTEMS OF ITS KIND. FORTUNATELY, THE EVENT HAS NOT LED TO SERIOUS INJURY OR WORSE. WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATIONS DUE TO CHAMBER ROLLER BEING STIFF AND CONTRIBUTED TO THE EVENT. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT WHEN THE EVENT TOOK PLACE. BASED ON THE PERFORMED ROOT CAUSE ANALYSIS AND INPUT FROM THE SUBJECT MATTER EXPERT AND THE GETINGE TECHNICIAN WHO VISITED THE CUSTOMER WE CONCLUDE TWO POSSIBLE FACTORS OF THE INCIDENT. - FIRST RELATED TO STIFF ROLLERS, MOST PROBABLE ROOT CAUSE IS RELATED TO MAINTENANCE. IT IS POSSIBLE THAT THIS CHECK WAS NOT PERFORMED CORRECTLY, OR THAT EARLY SYMPTOMS OF DAMAGE WERE NOT DETECTED OR NOTICEABLE AT THE TIME. - SECOND RELATED TO USAGE OF NON-APPROVED WHEELS BY THE USER. THIS VARIATION COULD OBSTRUCT THE MOVEMENT OF THE LOAD CAR OR PREVENT IT FROM MOVING. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICES, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES, WE WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION. THE PURPOSE OF THIS SUBMISSION IS ALSO TO PROVIDE A CORRECTION OF G SECTION. THIS IS BASED ON THE RESULT OF AN INTERNAL REVIEW NOTING THE REPORT DID NOT CONTAIN CORRECT INFORMATION. #G1 (CONTACT PERSON ¿ MFG SITE): PREVIOUS G1 (CONTACT PERSON ¿ MFG SITE): (B)(6). CORRECTED G1 (CONTACT PERSON ¿ MFG SITE): (B)(6).

Description of Event or Problem

MANUFACTURER'S REFERENCE NUMBER (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

Description of Event or Problem

ON (B)(6) 2024, GETINGE BECAME AWARE OF INCIDENT WITH THE 833HC-E STERILIZER. AS IT WAS STATED BY THE GETINGE TECHNICIAN, STAFF GOT BACK INJURED WHILE REMOVING A LOADED CART FROM THE STERILIZER AS THE CART GOT CAUGHT. NO DETAILED INFORMATION REGARDING THE INJURY WAS RECEIVED. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS THE DESCRIBED EVENT COULD LEAD TO SERIOUS INJURY.