LUCEA 40

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. EVENT SITE NAME:(B)(6). DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON 28TH MARCH 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED, THE HEADLIGHT COVER WAS BROKEN RESULTING IN MISSING PARTICLES. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.

Additional Manufacturer Narrative

THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM, H3A DEVICE EVALUATED BY MFG, H3B DEVICE NOT EVAL PROVIDE CODE AND H3C IF OTHER PROVIDE CODE-EXPLAIN DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 28TH MARCH 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED, THE HEADLIGHT COVER WAS BROKEN RESULTING IN MISSING PARTICLES. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 21ST MARCH 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED, THE HEADLIGHT COVER WAS BROKEN RESULTING IN MISSING PARTICLES. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. PREVIOUS H3A DEVICE EVALUATED BY MFG: NO. CORRECTED H3A DEVICE EVALUATED BY MFG: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: NONE PREVIOUS H3C IF OTHER PROVIDE CODE-EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER CORRECTED H3C IF OTHER PROVIDE CODE-EXPLAIN: NONE GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED, THE HEADLIGHT COVER WAS BROKEN RESULTING IN MISSING PARTICLES. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. BASED ON AN INFORMATION GATHERED, DEFECTIVE PARTS (HANDLE INTERFACE WITH FORK - LUCEA 40 ARD368605998 AND TRANSPARENT PLASTIC COVER - LUCEA 40 ARD368606555) WERE REPLACED AND THE DEVICE IS BACK IN USAGE AGAIN. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATION LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE, THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. ACCORDING TO THE ANALYSIS PERFORMED BY THE SUBJECT MATTER EXPERT, THE PROBABLE CAUSES OF THE BREAKAGE ARE THE INCOMPATIBILITY OF THE CLEANING PRODUCTS OR ABNORMAL USE. MAQUET SAS RECOMMENDS VISUAL INSPECTION BEFORE USE ACCORDING TO THE USER MANUAL. A DAILY INSPECTION PERFORMED BY THE USER (CHIPPED PAINT, IMPACT MARKS AND ANY OTHER DAMAGE) WILL HELP PREVENTING SUCH EVENT. MAQUET SAS ALSO RECOMMENDS TO INFORM THE CUSTOMERS ABOUT THE HAZARDS IN CASES OF NON-COMPLIANCE OF THESE INSTRUCTIONS. IN ORDER TO AVOID MECHANICAL STRESSES APPLIED ON THE TRANSPARENT HOUSING DURING USE THE USER MANUAL MENTIONS TO HANDLE THE LIGHT BY THE HANDLE. TO PREVENT SIMILAR EVENT, THE SAME USER MANUAL MENTIONS TO CHECK THE LIGHT HEADS DURING DAILY INSPECTION. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

Description of Event or Problem

ON 21TH MARCH 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED, THE HEADLIGHT COVER WAS BROKEN RESULTING IN MISSING PARTICLES. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.