LUCEA 10/40

Description of Event or Problem

ON 19TH JULY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10/40. BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVERS WERE CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION.

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

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

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10/40. BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVERS WERE CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATION LIGHT DID NOT MEET ITS SPECIFICATION, SINCE CRACKS IN COVERS, RESULTING IN MISSING PLASTIC PARTICLES 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 PATIENT TREATMENT. 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. ACCORDING TO THE ANALYSIS PERFORMED BY THE SUBJECT MATTER EXPERT, THE PROBABLE CAUSES OF THE BREAKAGE ARE THE INCOMPATIBILITY OF THE CLEANING PRODUCTS OR ABNORMAL USE. MAQUET SAS RECOMMENDS VISUAL INSPECTION BEFORE USE ACCORDING TO THE USER MANUAL (IFU 01701 REV. 12, PAGE 22-23). A DAILY INSPECTION PERFORMED BY THE USER (CHIPPED PAINT, IMPACT MARKS AND ANY OTHER DAMAGE) WILL HELP PREVENTING SUCH EVENT. MAQUET SAS ALSO RECOMMENDS TO INFORM THE CUSTOMERS ABOUT THE HAZARDS IN CASES OF NON-COMPLIANCE OF THESE INSTRUCTIONS. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER¿S 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. INITIAL REPORTER: THE PURCHASING DEPARTMENT.