LUCEA 40

Additional Manufacturer Narrative

THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 31ST AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. IT WAS STATED THE LIGHT SWITCH WAS BROKEN AND HAD FALLEN FROM THE DEVICE, AND ALSO THE INSIDE OF THE LIGHT BODY FORK WAS DAMAGED. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 31ST AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. IT WAS STATED THE LIGHT SWITCH WAS BROKEN AND HAD FALLEN FROM THE DEVICE. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. IT WAS STATED THE LIGHT SWITCH WAS BROKEN AND HAD FALLEN FROM THE DEVICE. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. ACCORDING TO THE INFORMATION PROVIDED BY GETINGE TECHNICIAN, THE ISSUE WAS SOLVED AFTER REPLACING THE WHOLE HANDLE INTERFACE WITH FORK (ARD368605998). IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATION LIGHT DID NOT MEET ITS SPECIFICATION DUE TO MISSING SWITCH FROM THE HEADLIGHT, WHICH CONTRIBUTED TO THE EVENT. PROVIDED INFORMATION DOES INDICATE THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. IT WAS DETECTED BY THE GETINGE TECHNICIAN WHO PERFORMED THE PREVENTIVE MAINTENANCE. REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS RELATED TO INVESTIGATED ISSUE, REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. WE CAN ASSUME THAT THE FAILURE RATIO OF MISSING SWITCH ON LUCEA 10/40 DEVICES IS VERY LOW. TECHNICAL ANALYSIS WAS PERFORMED BY THE SUBJECT MATTER EXPERT AT MAQUET SAS. AS THEY STATED, THE EXACT ROOT CAUSE OF THE BREAKAGE OF ON/OFF BUTTON COULD NOT BE DETERMINED, HOWEVER THERE ARE FEW PROBABLE ROOT CAUSE WHICH COULD LEAD TO THIS MALFUNCTION: IMPACT, COLLISIONS, IMPORTANT PRESSURE APPLIED (ABNORMAL USE). INAPPROPRIATE CLEANING PRODUCT. FOR MORE INFORMATION, PLEASE SEE THE ATTACHED EXTRACT FROM IFU 01701 EN 12 (PAGES 22, 29-30). WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION HAD BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

Description of Event or Problem

ON 31ST AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. IT WAS STATED THE LIGHT SWITCH WAS BROKEN AND HAD FALLEN FROM THE DEVICE. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.

Description of Event or Problem

ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. IT WAS STATED THE LIGHT SWITCH WAS BROKEN AND HAD FALLEN FROM THE DEVICE, AND ALSO THE INSIDE OF THE LIGHT BODY FORK WAS DAMAGED. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THE INITIAL REPORTER WAS CLINICAL ENGINEER. (B)(6) . H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.