LUCEA 10
Received May 28, 2021 · Event occurred Mar 17, 2021
Report 9710055-2021-00208 · MDR key 11900438
Device
Generic name
Device, Medical Examination, Ac Powered
Manufacturer
Maquet SasProduct 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
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
ON (B)(6) 2021 GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 10 DEVICE. AS IT WAS STATED, THE COVER WAS BROKEN OFF. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DETACHMENT OF PART OR PARTICLES MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.
Description of Event or Problem
MANUFACTURER REFERENCE NUMBER (B)(4).
Additional Manufacturer Narrative
GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 10 DEVICE. AS IT WAS STATED, THE COVER WAS BROKEN OFF. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DETACHMENT OF PART OR PARTICLES MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE LIGHT DID NOT MEET ITS SPECIFICATION AS THE COVER WAS BROKEN OFF AND IT CONTRIBUTED TO EVENT. THERE IS NO INFORMATION WHETHER THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. ACCORDING TO INFORMATION PROVIDED BY SALES AND SERVICE UNIT, THE COVER WAS BROKEN DUE TO CRASH. PROBABLE ROOT CAUSE IS IMPROPER USE OR IMPROPER HANDLING OF EQUIPMENT. IT IS NECESSARY TO REFER TO THE INSTRUCTION MANUAL FOR MORE INFORMATION (IFU 01701 EN 10 2021-03-17 PAGE 21). WE BELIEVE THAT THIS TYPE OF OUR DEVICES ARE PERFORMING CORRECTLY IN THE MARKET.