LUCEA 40

Additional Manufacturer Narrative

INITIAL REPORTER: GETINGE SERVICE TECHNICIAN. 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: CRE 12-085 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 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. TO PREVENT ANY INCIDENT THE LUCEA10/40 INSTRUCTION FOR USE IFU 01701 MENTIONS TO CHECK THE INTEGRITY OF THE LIGHT HEADS DURING DAILY INSPECTION. FURTHERMORE THE LUCEA10/40 INSTRUCTION FOR USE IFU 01701 EXPLAINS HOW TO CLEAN AND DISINFECT THE LIGHT HEADS. THIS DOCUMENT INCLUDES SOME RECOMMENDED PRODUCTS AND SOME PROHIBITED PRODUCTS. IN ORDER TO AVOID TORQUES APPLIED ON THE TRANSPARENT HOUSING DURING USE THE LUCEA10/40 INSTRUCTION FOR USE IFU 01701 MENTIONS TO HANDLE THE LIGHT HEAD BY THE HANDLE (PLEASE SEE ATTACHED IFU_LUCEA_10_40_01701EN12, PAGES 22-25, 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

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

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1B EVENT SITE NAME: (B)(6) . E1 EVENT SITE TELEPHONE: (B)(6) . H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON 23RD OCTOBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED, UPON THE PREVENTIVE MAINTENANCE ACTIVITIES BEING PERFORMED ON THE DEVICE, THE PLASTIC AROUND THE MOUNTING SCREWS ON THE HEADLIGHT'S COVER AND THE TRANSPARENT COVER AT THE FASTENINGS WERE FOUND TO BE BROKEN WITH MISSING PARTICLES. 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.