LUCEA 40

Additional Manufacturer Narrative

ACCORDING TO THE REPORTING TIMEFRAME WE WOULD LIKE TO PROVIDE THE INFORMATION ABOUT CURRENT STATUS OF THE ISSUE. PLEASE BE ADVISED THAT IT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 27TH APRIL, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE HEADLIGHT FELL DOWN ON THE GROUND. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE SERIOUS INJURY. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 27TH APRIL, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40 (MOBILE VERSION). IT WAS STATED THE PERSONNEL IN CHARGE OF BIOCLEANING REVERSED THE LIGHTING AND THE LIGHT FELL DOWN ON THE GROUND. CURRENTLY THE LIGHTING IS OUT OF USE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY MOBILE DEVICE FALLING ON THE GROUND DURING EXAMINATION PROCEDURE MAY CAUSE SERIOUS INJURY.

Description of Event or Problem

ON 27TH APRIL, 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40 (MOBILE VERSION). IT WAS STATED THE PERSONNEL IN CHARGE OF BIOCLEANING REVERSED THE LIGHTING AND THE LIGHT FELL DOWN ON THE GROUND. CURRENTLY THE LIGHTING IS OUT OF USE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY MOBILE DEVICE FALLING ON THE GROUND DURING EXAMINATION PROCEDURE MAY CAUSE SERIOUS INJURY.

Description of Event or Problem

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

Additional Manufacturer Narrative

THE DEVICE REFERENCE NUMBER FOR THE MEDICAL DEVICE REFERRED TO IN THIS MEDICAL DEVICE REPORT CANNOT BE VERIFIED, AND THEREFORE, NO UDI NUMBER CAN BE PROVIDED. 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. PREVIOUS H6 MEDICAL DEVICE ¿ PROBLEM CODE: MECHANICAL PROBLEM/DETACHMENT OF DEVICE OR DEVICE COMPONENT//2907. CORRECTED H6 MEDICAL DEVICE ¿ PROBLEM CODE: MECHANICAL PROBLEM/UNINTENDED MOVEMENT/DEVICE FELL/4014. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS ¿ LUCEA. IT WAS DISCOVERED THAT THE PERSONNEL IN CHARGE OF BIOCLEANING REVERSED THE LIGHTING AND THE LIGHT FELL DOWN ON THE GROUND. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THE ISSUE CAN CAUSE SERIOUS INJURY IN CASE OF REOCCURRENCE. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID MEET ITS SPECIFICATION AND THE DEVICE DID NOT CONTRIBUTED TO EVENT. THE CLAIMED DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERT AT MANUFACTURER¿S SITE. IT WAS STATED THAT IT IS CLEARLY MENTIONED THAT THE STAFF WHO PERFORM THE CLEANING CAUSED THE MOBILE LIGHT TO FALL. THE ROOT CAUSE IS CLEARLY IDENTIFIED AND IT IS NOT DURING USE OF THE LIGHT. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON 27TH APRIL, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE HEADLIGHT FELL DOWN ON THE GROUND. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE SERIOUS INJURY.