LUCEA 40
Received Oct 11, 2022 · Event occurred Sep 30, 2022
Report 9710055-2022-00416 · MDR key 15579477
Device
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
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 30TH SEPTEMBER, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE SWITCH WAS MISSING FROM HEADLIGHT. 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.
Additional Manufacturer Narrative
THE CORRECTION OF H4 MANUFACTURE DATE DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H4 MANUFACTURE DATE 02/29/2016. CORRECTED H4 MANUFACTURE DATE 03/04/2016. 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.
Description of Event or Problem
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Additional Manufacturer Narrative
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE SWITCH WAS MISSING FROM HEADLIGHT. 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. TECHNICIAN INFORMED THAT TEMPORARY REPAIR WAS ACCOMPLISHED THE HOUSING WAS SLIGHTLY DAMAGED AND REPLACEMENT OF HOUSING IS RECOMMENDED. THE LIGHT IS FUNCTIONAL AND QUOTE FOR REPLACEMENT OF THE HOUSING WAS SUPPLIED. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION DUE TO THE REPORTED DEFECT, WHICH CONTRIBUTED TO THE REPORTABLE SITUATION. BASED ON INFORMATION COLLECTED IT WAS NOT POSSIBLE TO ESTABLISH THAT THE AFFECTED DEVICE WAS OR WAS NOT BEING USED FOR THE PATIENT TREATMENT UPON THE EVENT OCCURRENCE. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUE HAS NEVER LED TO SERIOUS INJURY OR WORSE, TO OUR KNOWLEDGE. COMPARING THE NUMBER OF AFFECTED DEVICES BY THE INVESTIGATED ISSUE TO THE INSTALL BASE, COMPLAINT RATIO IS VERY LOW. AS STATED BY SUBJECT MATTER EXPERT AT THE MANUFACTURING SITE, MAQUET SAS DID NOT RECEIVE ENOUGH INFORMATION TO CONDUCT THE TECHNICAL INVESTIGATION. NEVERTHELESS THE PROBABLE CAUSES OF THE DETERIORATION OF THE BUTTON MAY BE DUE TO COLLISION OR EXCESSIVE EFFORT. 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).