LUCEA 40

Additional Manufacturer Narrative

THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER?, H3B DEVICE NOT EVAL PROVIDE CODE AND 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. IT WAS STATED THE UPPER FIXING POINT OF THE TRANSPARENT SHELL WAS BROKEN. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER AT THE ATTACHMENT POINT OF THE UPPER HEADLIGHT COVERS WAS CRACKED WITH MISSING PARTICLES. 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 MISSING PARTICLES, WHICH CONTRIBUTED TO THE EVENT. PROVIDED INFORMATION DOES NOT INDICATE, WEATHER THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT, WHILE ISSUE OCCURRED. A ROOT CAUSE ANALYSIS FOR MISSING PARTICLES PROBLEM WAS PERFORMED BY SUBJECT MATTER EXPERTS AND CONCLUDED THAT 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 INSTRUCTION FOR USE MENTIONS TO CHECK THE INTEGRITY OF THE LIGHT HEADS DURING DAILY INSPECTION. FURTHERMORE THE INSTRUCTION FOR USE 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 INSTRUCTION FOR USE MENTIONS TO HANDLE THE LIGHT HEAD BY THE HANDLE. 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

INITIAL REPORTER WAS HOSPITAL 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 20TH NOVEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE UPPER FIXING POINT OF THE TRANSPARENT SHELL WAS BROKEN. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER AT THE ATTACHMENT POINT OF THE UPPER HEADLIGHT COVERS WAS CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE INFECTION.