LUCEA 10/40
Received Jan 11, 2023 · Event occurred Jan 6, 2023
Report 9710055-2023-00025 · MDR key 16138892
Device
Generic name
Device, Medical Examination, Ac Powered
Manufacturer
Maquet SasModel number
ARD368605998Catalog number
ARD368605998
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 6TH JANUARY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE HEADLIGHT COVERS WERE CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION.
Additional Manufacturer Narrative
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 HEADLIGHT COVERS WERE CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. THERE IS NO INFORMATION IF THE CLAIMED DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. ACCORDING TO THE ANALYSIS PERFORMED BY THE SUBJECT MATTER EXPERT, THE PROBABLE CAUSES OF THE BREAKAGE ARE THE INCOMPATIBILITY OF THE CLEANING PRODUCTS OR ABNORMAL USE. MAQUET SAS RECOMMENDS VISUAL INSPECTION BEFORE USE ACCORDING TO THE USER MANUAL. A DAILY INSPECTION PERFORMED BY THE USER (CHIPPED PAINT, IMPACT MARKS AND ANY OTHER DAMAGE) WILL HELP PREVENTING SUCH EVENT. MAQUET SAS ALSO RECOMMENDS INFORMING THE CUSTOMERS ABOUT THE HAZARDS IN CASES OF NON-COMPLIANCE OF THESE INSTRUCTIONS. 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).