700-SERIES

Additional Manufacturer Narrative

THE ISSUE IS BEING INVESTIGATED BY THE MANUFACTURING SITE. DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON (B)(6) GETINGE BECAME AWARE ABOUT AN INCIDENT WHEN LOAD RACK CAME OFF TROLLEY WHEN THE OPERATOR WAS UNLOADING THE STERILIZED ITEMS. THE TROLLEY MOVED AWAY, HURTING OPERATORS' ARM. THE HARM WAS NOT CLASIFIED AS SERIOUS, HOWEVER WE DECIDED TO REPORT THIS CASE AS THE POTENTIAL RISK OF THE SERIOUS INJURY.

Additional Manufacturer Narrative

GETINGE BECAME INFORMED OF AN ISSUE WITH A ¿TROLLEY LOCKING¿ ISSUE WHILE PREPARING USE OF A STEAM STERILIZER 733HC-E DEVICE WITH SERIAL NUMBER (B)(6) AS IT WAS STATED, THE LOAD RACK CAME OFF FROM TROLLEY WHEN THE OPERATOR WAS UNLOADING THE STERILIZED ITEMS. THE TROLLEY DID NOT LOCK TO THE STERILIZER PROPERLY AND MOVED AWAY, HURTING OPERATORS' SHOULDER, CAUSING MINOR INJURY. THE CUSTOMER ALLEGATION WAS, THAT THE TROLLEY DOES NOT LOCK SOMETIMES. GETINGE TECHNICIAN ARRIVED ON PLACE AND ADJUSTED THE LOCKING BRACKET ON THE TROLLEY. HE RETURNED THE DEVICE TO THE CUSTOMERS¿ USAGE. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE ABLE TO ESTABLISH THAT THE RECEIVED INCIDENT IS THE FOURTH ONE REGISTERED IN GETINGE COMPLAINT HANDLING SYSTEMS WHERE THE PROBLEM WITH TROLLEY LOCKING TO THE STERILIZER APPEARS ON 700-SERIES STERILIZERS TO DUE VARIOUS REASONS OVER A PERIOD OF 5 YEARS. FORTUNATELY, THE EVENT HAS NOT LED TO SERIOUS INJURY OR WORSE. WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION DUE TO LOCKING MECHANISM MALFUNCTION AND IT CONTRIBUTED TO EVENT. THE PROVIDED INFORMATION DID NOT INDICATE THAT THE DEVICE WAS BEING USED FOR PATIENT TREATMENT WHEN THE EVENT TOOK PLACE. BASED ON PERFORMED ROOT CAUSE ANALYSIS WE CONCLUDE THAT THE CAUSE OF THE EVENT WAS TROLLEY LOCKING MECHANISM MALFUNCTIONING AND NEEDED ADJUSTMENT THAT WAS PERFORMED BY SERVICE TECHNICIAN AFTER THE EVENT. MALFUNCTION MIGHT HAVE BEEN CAUSED BY EXTERNAL MECHANICAL FORCE THAT LEAD TO MISALIGNMENT OF THE MECHANISM ELEMENTS. THE LOCKING MECHANISM SHOULD BE REVIEWED QUARTERLY IN ORDER TO PERFORM CORRECTLY. THE USER IS ALSO REMINDED OF THE USER MANUAL AS SUPPLIED WITH THE DEVICE; TO CHECK THAT THE TROLLEY IS LOCKED SECURELY EACH TIME USING THE TROLLEY IN ORDER TO PREVENT THE DESCRIBED ISSUE, AND NOT TO ATTEMPT TO LIFT THE TROLLEY IF IT FALLS DOWN. PREVENTIVE MAINTENANCE OF THE DEVICE INVOLVED HAS BEEN PERFORMED UNDER GETINGE SERVICE AGREEMENT. ACCORDING TO USER MANUAL (61301606344 REV B) USER SHOULD CHECK IF THE TRANSFERRING CARRIAGE IS LOCKED TO THE STERILIZER DURING LOADING OR UNLOADING THE DEVICE TO PREVENT A SITUATION DESCRIBED IN THE COMPLAINT WHERE THE TROLLEY MOVED AWAY FROM THE STERILIZER. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICE MANUFACTURING OR DEVICES ON THE MARKET, 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 259763.

Description of Event or Problem

MANUFACTURER REFERENCE NUMBER: (B)(4).

Additional Manufacturer Narrative

THE ISSUE IS BEING INVESTIGATED BY THE MANUFACTURING SITE.