500-SERIES

Additional Manufacturer Narrative

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

Description of Event or Problem

ON 16TH OCTOBER, 2019 GETINGE BECAME AWARE OF THE PROBLEM WITH ONE OF THE STERILIZERS, 533-HC. THE CUSTOMER NOTICED THE DOOR DID NOT OPEN. WHEN CUSTOMER OPENED THE DOOR MANUALLY, STEAM ISSUED FROM THE CHAMBER TO THE ROOM. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THIS EVENT BASING ON THE RISK OF POTENTIAL SERIOUS INJURY OR DEATH.

Description of Event or Problem

MANUFACTURER REFERENCE NUMBER OT257797.

Additional Manufacturer Narrative

THE ISSUE IS STILL BEING INVESTIGATED BY THE MANUFACTURING SITE.

Description of Event or Problem

MANUFACTURER REFERENCE NUMBER 257797.

Additional Manufacturer Narrative

GETINGE BECAME INFORMED OF AN ISSUE WITH A STEAM STERILIZER 533HC DEVICE WITH SERIAL NUMBER URA013192. INITIALLY, THE CUSTOMER NOTICED THE DOOR DID NOT OPEN. AFTER FEW ATTEMPTS, THE CUSTOMER MANAGED TO OPEN THE DOOR MANUALLY AND STEAM ISSUED FROM THE CHAMBER TO THE ROOM. THERE WASN'T ANY INJURY REPORTED DUE TO THIS CASE, HOWEVER WE DECIDED TO REPORT THIS CASE IN ABUNDANCE OF CAUTION AS ANY UNEXPECTED STEAM LEAK UNDER THE PRESSURE AND FROM PARTS AVAILABLE TO THE CUSTOMER MIGHT LEAD TO AN ADVERSE OUTCOME. IT WAS DECIDED TO REPORT THIS ISSUE BASED ON THE POTENTIAL RELATED TO WORST CASE SCENARIO. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE ABLE TO ESTABLISH THAT THE RECEIVED INCIDENT IS THE SIXTH ONE REGISTERED IN GETINGE COMPLAINT HANDLING SYSTEMS FOR STEAM LEAK FROM DOOR APPEARS ON 500-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 VALVE 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 STEAM ESCAPE WAS THE STEAM TO CHAMBER VALVE MALFUNCTION - THE VALVE WAS LEAKING STEAM INTO THE STERILIZER CHAMBER. THE ROOT CAUSE OF THE VALVE MALFUNCTION CANNOT BE CLEARLY DETERMINED DUE TO LACK OF INFORMATION ABOUT PREVENTIVE MAINTENANCE OF THE STERILIZER. PREVENTIVE MAINTENANCE OF THE DEVICE INVOLVED HAS NOT BEEN PERFORMED UNDER GETINGE SERVICE AGREEMENT. AT THIS POINT, WE DO NOT HAVE A CONFIRMATION THAT THE VALVE WAS CHECKED/REPLACED YEARLY AS SUGGESTED IN PRODUCT TECHNICAL MANUAL. THE STERILIZER IS EQUIPPED WITH SAFETY FEATURE NOT ALLOWING USER TO OPEN THE DOOR IF PRESSURE IN THE CHAMBER IS HIGHER THAN 2PSIG. USER SHOULD NOT ATTEMPT TO OPEN THE DOOR IF THERE IS PRESSURE IN CHAMBER WHAT CAN BE CHECKED BY GAUGE LOCATED IN FRONT OF STERILIZER OR IN A STERILIZER DISPLAY. ACCORDING TO USER MANUAL 6013019401 REV A US THERE ARE PROVIDED INFORMATION ABOUT STERILIZER USES HOT WATER AND STEAM, WHICH HAVE THE POTENTIAL OF CAUSING BURNS OR SERIOUS INJURIES. WEAR PERSONAL PROTECTIVE EQUIPMENT SUITABLE FOR HOT WATER AND STEAM. MANUAL ALSO PROVIDE INFORMATION HOW TO OPEN THE DOOR WITH INFORMATION TO ALLOWS ANY RESIDUAL STEAM TO ESCAPE. 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.

Additional Manufacturer Narrative

THE ISSUE IS BEING INVESTIGATED BY THE MANUFACTURING SITE.

Description of Event or Problem

MANUFACTURER REFERENCE NUMBER: (B)(4).