LUCEA 40

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON (B)(6) 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. DURING ANNUAL MAINTENANCE IT WAS NOTICED THE COVER OF THE SPRING ARM WAS MISSING. IT WAS ALSO CONFIRMED BY PHOTOGRAPHIC EVIDENCE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION.

Additional Manufacturer Narrative

THE CORRECTION OF H4 MANUFACTURE DATE DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H4 MANUFACTURE DATE: 2012-10-01. CORRECTED H4 MANUFACTURE DATE: 2013-05-14. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. DURING ANNUAL MAINTENANCE IT WAS NOTICED THE COVER OF THE SPRING ARM WAS MISSING. IT WAS ALSO CONFIRMED BY PHOTOGRAPHIC EVIDENCE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION. BASED ON AN INFORMATION GATHERED, DEFECTIVE CAP SPRING ARM BLUE 30 NEW RAL9016 (ARD569010102) HAS BEEN REPLACED. 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 DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT UPON THE EVENT OCCURRENCE. ACCORDING TO THE INFORMATION GATHERED, THE ISSUE WAS DISCOVERED BY GETINGE TECHNICIAN DURING MAINTENANCE. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUE WE WERE ABLE TO ESTABLISH THAT THE RECEIVED INCIDENTS ARE OCCURRING AT A VERY LOW 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 (TECHNICAL MANUAL 0170201, 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). 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).