LUCEA 40

Description of Event or Problem

ON 19TH JANUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED THE ON/OFF BUTTON HAS FALLEN OFF. 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. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

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 MFG, H3B DEVICE NOT EVAL PROVIDE CODE AND H3C IF OTHER PROVIDE CODE-EXPLAIN DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. 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 DEVICE NOT EVAL PROVIDE CODE: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C DEVICE NOT EVAL PROVIDE CODE: NONE. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED THE ON/OFF BUTTON HAS FALLEN OFF. 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. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATION LIGHT DID NOT MEET ITS SPECIFICATION DUE TO BUTTON FALLING OFF, WHICH CONTRIBUTED TO THE EVENT. IT IS UNKNOWN IF THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT UPON THE EVENT OCCURRENCE. 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 PARTICLES ON LUCEA 10/40 DEVICES IS MODERATE. A ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERTS AT MANUFACTURING SITE. IT WAS DETECTED THAT THE ON/OFF ROCKER SWITCH HM56019505 OF THE LUCEA40 LIGHT HEAD WAS MISSING. THE CAUSE OF THIS DAMAGE IS PROBABLY A MECHANICAL SHOCK. TO PREVENT ANY INCIDENTS, THE INSTRUCTION FOR USE OPERATING INSTRUCTIONS MENTIONS : "THIS LIGHT MUST NOT BE USED IF IT IS DAMAGED." "CHECK THAT THE DEVICE HAS NOT SUFFERED ANY IMPACT DAMAGE." DURING DAILY CHECKS BEFORE USE. THE INSTRUCTION FOR USE MENTIONS THAT THE LUCEA 40 IS A DIAGNOSTIC LAMP INTENDED FOR LOCAL ILLUMINATION OF THE PATIENT'S BODY TO FACILITATE DIAGNOSTIC OR TREATMENT PROCEDURES THAT CAN BE DISCONTINUED WITHOUT RISK TO THE PATIENT IN THE EVENT OF LAMP FAILURE. IT IS NOT INTENDED FOR USE IN THE OPERATING ROOM. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.