LUCEA 40

Description of Event or Problem

MANUFACTURER'S REFERENCE NUMBER (B)(4).

Additional Manufacturer Narrative

THE CORRECTION OF D4 CATALOG # DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D4 CATALOG # ARDLCA209000C. CORRECTED D4 CATALOG # ARD568601998. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED THE CAP COVER ON SPRING ARM (PART NUMBER ARD569010102) WAS MISSING. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. ACCORDING TO THE INFORMATION GATHERED, MISSING CAP (ARD569010102) WAS REFITTED ONTO THE SPRING ARM BY GETINGE TECHNICIAN. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATION LIGHT DID NOT MEET ITS SPECIFICATION, SINCE DETACHMENT OF COVER COULD BE CONSIDERED AS TECHNICAL DEFICIENCY, AND IN THIS WAY THE DEVICE CONTRIBUTED TO THE EVENT. THE PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE THE DEVICE WAS OR WAS NOT BEING USED FOR TREATMENT OR DIAGNOSIS PURPOSES. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUE WE WERE ABLE TO ESTABLISH THAT THE RECEIVED INCIDENTS ARE OCCURRING AT A MODERATE RATIO. WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUE HAS NEVER LED TO SERIOUS INJURY OR WORSE, TO OUR KNOWLEDGE. AS STATED BY SUBJECT MATTER EXPERT AT MAQUET SAS, THE MOST PROBABLE ROOT CAUSE OF THE BREAK OF THIS CAP IS REPEATED AND VIOLENT SHOCKS DURING THE USE OF THE DEVICE. ANOTHER PROBABLE ROOT CAUSE IS THAT THE CAP HAS BEEN FORGOTTEN OR DETERIORATED AFTER A READJUSTMENT OF THE SPRING ARM DURING THE MAINTENANCE OF MEDICAL DEVICE. THE YEARLY PREVENTIVE MAINTENANCE PROGRAM DOCUMENTED IN THE TECHNICAL MANUAL FOR LUCEA 10/40 (0170201 1K) ON PAGE 10 MENTIONS TO CHECK THE FIXING OF ALL CAPS. THE CAP MUST BE REINSTALLED DURING INSTALLATION OR AFTER THE MAINTENANCE PROCEDURE. MAQUET SAS STRONGLY ADVISES TO CHECK SIMILAR DEVICES IN THE HOSPITAL IN ORDER TO CHECK THE PRESENCE OF ALL SPRING ARMS CAPS. IF A MISSING CAP IS NOTICED, A NEW ONE SHOULD BE ORDERED AS SPARE PARTS. (BLUE 30 / LUCEA 40-50 : ARD569010102) WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER 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.

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) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED THE CAP COVER ON SPRING ARM (PART NUMBER ARD569010102) WAS MISSING. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.