LUCEA 40

Additional Manufacturer Narrative

THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE SEPTEMBER 2016. 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. IT WAS STATED THE DOME WAS DAMAGED DUE TO HIT. THE DESIGNATED COMPLAINT UNIT EMPLOYEE FOUND ON PHOTOGRAPHIC EVIDENCE THAT THE HEADLIGHT COVER WAS CRACKED WITH POSSIBILITY OF MISSING PARTICLES AND THE CONNECTION BETWEEN THE FORK AND THE HEADLIGHT WAS LOOSE AND THE HEADLIGHT LOOKED LIKE IT COULD FALL OFF. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE INFECTION IN CASE OF REOCCURRENCE. DEFECTIVE PARTS HANDLE INTERFACE WITH FORK - LUCEA 40 (ARD368605998) AND HANDLE INTERFACE WITH FORK - LUCEA 40 (ARD600970308) WERE REPLACED AND DEVICE WAS BACK TO USAGE. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATION 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 DAILY CHECK. AS STATED BY SUBJECT MATTER EXPERT AT THE MANUFACTURING SITE, THE MOST LIKELY ROOT CAUSE IS A VIOLENT ROTATION OF THE LIGHT HEAD. THE TEST RE11-052 PROVES THAT THE STOP RESISTS TO 50 STRONG ROTATIONS AND IS COMPLIANT TO THE STANDART UL60601-1. FURTHERMORE THESE CASES REMAIN ISOLATED. 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

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

Description of Event or Problem

ON 22ND NOVEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE DOME WAS DAMAGED DUE TO HIT. THE DESIGNATED COMPLAINT UNIT EMPLOYEE FOUND ON PHOTOGRAPHIC EVIDENCE THAT THE HEADLIGHT COVER WAS CRACKED WITH POSSIBILITY OF MISSING PARTICLES AND THE CONNECTION BETWEEN THE FORK AND THE HEADLIGHT WAS LOOSE AND THE HEADLIGHT LOOKED LIKE IT COULD FALL OFF. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE INFECTION IN CASE OF REOCCURRENCE.

Additional Manufacturer Narrative

INITIAL REPORTER WAS MAINTENANCE/ELECTROMEDICINE SERVICE. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.