LUCEA 40

Description of Event or Problem

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

Additional Manufacturer Narrative

INITIAL REPORTER WAS GETINGE TECHNICIAN. THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO. CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. DURING PREVENTIVE MAINTENANCE THE CRACKED COVERS WERE DISCOVERED. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE HEADLIGHT WAS CRACKED WITH POSSIBILITY OF MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT UPON THE EVENT OCCURRENCE. ACCORDING TO THE INFORMATION GATHERED, THE ISSUE WAS DISCOVERED DURING PREVENTIVE MAINTENANCE. 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 (IFU 01701 REV. 12, PAGE 22-23). 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. 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 (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. DURING PREVENTIVE MAINTENANCE IT WAS DISCOVERED THE TRANSPARENT COVER BROKE OFF DURING THE FASTENINGS AND THE USER REATTACH THE COVER WITH ADHESIVE TAPE. SMALL PARTS OF THE COVER WERE MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION.

Additional Manufacturer Narrative

EVENT SITE TELEPHONE (B)(6). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.