LUCEA 40
Received Apr 28, 2021 · Event occurred Apr 15, 2021
Report 9710055-2021-00148 · MDR key 11738095
Device
Generic name
Device, Medical Examination, Ac Powered
Manufacturer
Maquet SasModel number
ARD568601997Catalog number
ARD568601997
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 40 LIGHT. THE HEAD LIGHT COVER WAS DAMAGED AND PARTICLES WERE MISSING, THE ISSUE WAS CONFIRMED BY A PHOTOGRAPHIC EVIDENCE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF MAY CAUSE POTENTIAL INFECTION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE LIGHT DID NOT MEET ITS SPECIFICATION AS THE COVER WAS DAMAGED AND PARTICLES WERE MISSING AND IT CONTRIBUTED TO EVENT. IN THE TIME WHEN THE EVENT OCCURRED, THE DEVICE WAS BEFORE USE FOR PATIENT DIAGNOSIS. THE CRACKS DETECTED AT THE EDGE OF THE FIXING HOLES OF TRANSPARENT HOUSING AND HANDLE INTERFACE WERE PROBABLY CAUSED BY THE INCOMPATIBILITY OF THE CLEANING PROTOCOL OR AN ABNORMAL USE. THE USER MANUAL 01701 EN 10 PAGE 27 ¿ 29 DESCRIBES 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, IFU 01701 EN PAGE 23-24 MENTIONS TO HANDLE THE LIGHT HEAD BY THE HANDLE. THE CLEANING AND HANDLING TESTS PERFORMED BY GETINGE (REF. CRE 12-085) DID NOT LEAD TO CRACKS AS REPORTED IN THE COMPLAINTS. TO PREVENT SIMILAR EVENT THE USER MANUAL 01701 EN 10 PAGE 20 MENTIONS TO CHECK THE LIGHT HEAD DURING DAILY INSPECTION. WE BELIEVE THAT THIS TYPE OF OUR DEVICES ARE PERFORMING CORRECTLY IN THE MARKET.
Description of Event or Problem
MANUFACTURER REFERENCE NUMBER (B)(4).
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 15TH APRIL 2021, GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 40 LIGHT. THE HEAD LIGHT COVER WAS DAMAGED AND PARTICLES WERE MISSING, THE ISSUE WAS CONFIRMED BY A PHOTOGRAPHIC EVIDENCE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF MAY CAUSE POTENTIAL INFECTION.