LUCEA 10/40

Additional Manufacturer Narrative

THE INITIAL REPORTER WAS GETINGE TECHNICIAN. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON (B)(6) 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. DURING PREVENTIVE MAINTENANCE IT WAS FOUND THE DOME COVER WAS DAMAGED. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER WAS CRACKED WITH MISSING PARTICLES AROUND THE SCREWS. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE INFECTION.

Additional Manufacturer Narrative

THE CORRECTION OF H4 MANUFACTURE DATE DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H4 MANUFACTURE DATE: 2013-09-02, CORRECTED H4 MANUFACTURE DATE: 2013-07-31. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. DURING PREVENTIVE MAINTENANCE IT WAS FOUND THE DOME COVER WAS DAMAGED. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER WAS CRACKED WITH MISSING PARTICLES AROUND THE SCREWS. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE INFECTION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATION LIGHT DID NOT MEET ITS SPECIFICATION DUE TO DAMAGE OF DOME COVER WITH MISSING PARTICLES, WHICH CONTRIBUTED TO THE EVENT. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT UPON THE EVENT OCCURRENCE. ACCORDING TO THE INFORMATION GATHERED, THE ISSUE WAS DISCOVERED BY GETINGE TECHNICIAN DURING 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 CRACKS AND MISSING PARTICLES ON LUCEA 10/40 DEVICES IS MODERATE. A ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERTS AT MANUFACTURING SITE. BASED ON SOME INTERNAL TEST DONE BY MAQUET SAS (REF: (B)(4) FOR INSTANCE), ONLY ABNORMAL USE (VIOLENT COLLISIONS, EXCESSIVE PRESSURE¿) OR THE USE OF INCOMPATIBLE CLEANING PRODUCTS OR PROTOCOL, CAN DAMAGE THIS DEVICE AS REPORTED IN THIS COMPLAINT. TESTS PERFORMED BY GETINGE DID NOT LEAD TO CRACKS AS REPORTED IN THE COMPLAINT AT HAND. THE CRACKS DETECTED ON THE HANDLE INTERFACE AND TRANSPARENT COVER FIXING POINTS WERE PROBABLY CAUSED BY IMPROPER USE, COLLISIONS, INCOMPATIBLE CLEANING PRODUCTS OR PROTOCOL. TO PREVENT ANY INCIDENT THE LUCEA10/40 INSTRUCTION FOR USE IFU 01701 MENTIONS TO CHECK THE INTEGRITY OF THE LIGHT HEADS DURING DAILY INSPECTION AND DESCRIBES HOW TO CLEAN AND DISINFECT THE LIGHT HEAD. THIS DOCUMENT INCLUDES SOME RECOMMENDED PRODUCTS AND SOME PROHIBITED PRODUCTS. IN ORDER TO AVOID MECHANICAL STRESSES APPLIED ON THE TRANSPARENT HOUSING DURING USE THE LUCEA10/40 INSTRUCTION FOR USE IFU 01701 MENTIONS TO HANDLE THE LIGHT HEAD BY THE HANDLE (IFU_LUCEA_10_40_01701EN12_EXTRACT, PAGES 22-25, 30). 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

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