LUCEA 40
Received Dec 9, 2022 · Event occurred Dec 7, 2022
Report 9710055-2022-00511 · MDR key 15948484
Device
Generic name
Device, Medical Examination, Ac Powered
Manufacturer
Maquet SasModel number
ARD568601999Catalog number
ARD568601999
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6)2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE COVER DROPPED FROM THE HEADLIGHT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.
Additional Manufacturer Narrative
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE COVER DROPPED FROM THE HEADLIGHT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATION LIGHT DID NOT MEET ITS SPECIFICATION DUE TO DETACHMENT OF COVER, WHICH CONTRIBUTED TO THE EVENT. PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. 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 DETACHMENT OF COVER ON LUCEA 10/40 DEVICES IS MODERATE. AS STATED BY SUBJECT MATTER EXPERT AT MANUFACTURING SITE, CRACKS WERE DETECTED AT THE EDGE OF FIXING HOLES OF TRANSPARENT HOUSING AND HANDLE INTERFACE WERE PROBABLY CAUSED BY THE INCOMPATIBILITY OF THE CLEANING PROTOCOL OR AN ABNORMAL USE. USER MANUAL FOR LUCEA 10/40 DESCRIBES HOW TO CLEAN AND DISINFECT THE LIGHT HEADS (NU_01701EN_12, PAGES 29-30). THIS DOCUMENT INCLUDES SOME OF THE RECOMMENDED AND PROHIBITED PRODUCTS. IN ORDER TO AVOID MECHANICAL STRESSES APPLIED ON THE TRANSPARENT HOUSING DURING USE THE USER MANUAL MENTIONS TO HANDLE THE LIGHT BY THE HANDLE. TO PREVENT SIMILAR EVENT, THE SAME USER MANUAL MENTIONS TO CHECK THE LIGHT HEADS DURING DAILY INSPECTION (PAGE 22 OF NU_01701EN_12). WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER¿S RECOMMENDATION HAD BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. 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).