LUCEA 40

Description of Event or Problem

ON 11TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. DURING ROUTINE PREVENTIVE MAINTENANCE PERFORMED ON THE DEVICE THE GETINGE TECHNICIAN DISCOVERED THE COVER MISSING FROM THE SPRING ARM. ADDITIONALLY THE PLASTIC ON THE TOP SCREW OF THE BRACKET WITH HANDLE WAS BROKEN WITH MISSING PARTICLES, IT WAS ESTABLISHED THE PARTICLES HAVE FALLEN OFF. IT WAS STATED THAT THE CRACKS HAVE BEEN ALSO FORMED ON THE FASTENINGS OF THE COVER, WHAT WAS CONFIRMED BY THE PHOTOGRAPHIC EVIDENCE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION.

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. DURING ROUTINE PREVENTIVE MAINTENANCE PERFORMED ON THE DEVICE THE GETINGE TECHNICIAN DISCOVERED THE COVER MISSING FROM THE SPRING ARM. ADDITIONALLY THE PLASTIC ON THE TOP SCREW OF THE BRACKET WITH HANDLE WAS BROKEN WITH MISSING PARTICLES, IT WAS ESTABLISHED THE PARTICLES HAVE FALLEN OFF. IT WAS STATED THAT THE CRACKS HAVE BEEN ALSO FORMED ON THE FASTENINGS OF THE COVER, WHAT WAS CONFIRMED BY THE PHOTOGRAPHIC EVIDENCE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION. DEVICE WAS REPAIRED AND BACK TO USAGE. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATION LIGHT DID NOT MEET ITS SPECIFICATION DUE TO CRACKS AND MISSING PARTICLES FROM COVER AS WELL AS MISSING COVER, WHICH 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. REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS RELATED TO INVESTIGATED ISSUE, REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. WE CAN ASSUME THAT THE FAILURE RATIO OF MISSING./ CRACK COVER ON LUCEA 10/40 DEVICES IS MODERATE. AS STATED BY SUBJECT MATTER EXPERT AT MANUFACTURING SITE, CRACKS WERE DETECTED AT THE EDGE OF FIXING HOLES OF TRANSPARENT HOUSING AND HANDLE INTERFACE WERE PROBABLY CAUSED BY THE INCOMPATIBILITY OF THE CLEANING PROTOCOL OR AN ABNORMAL USE. USER MANUAL FOR LUCEA 10/40 DESCRIBES HOW TO CLEAN AND DISINFECT THE LIGHT HEADS (NU_01701EN_11, PAGES 28-29). THIS DOCUMENT INCLUDES SOME OF THE RECOMMENDED AND PROHIBITED PRODUCTS. IN ORDER TO AVOID MECHANICAL STRESSES APPLIED ON THE TRANSPARENT HOUSING DURING USE THE USER MANUAL MENTIONS TO HANDLE THE LIGHT BY THE HANDLE. TO PREVENT SIMILAR EVENT, THE SAME USER MANUAL MENTIONS TO CHECK THE LIGHT HEADS DURING DAILY INSPECTION (PAGE 21 OF NU_01701EN_11). ADDITIONALLY, AS ALSO 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. INITIAL REPORTER: GETINGE SERVICE TECHNICIAN. THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM, H6 MEDICAL DEVICE ¿ PROBLEM CODE AND H6 COMPONENT CODES FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION AS PAINT CHIPPING ISSUE WAS INCLUDED IN THE INITIAL REPORTING BY MISTAKE. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 11TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. DURING ROUTINE PREVENTIVE MAINTENANCE PERFORMED ON THE DEVICE THE GETINGE TECHNICIAN DISCOVERED THE COVER MISSING FROM THE SPRING ARM. ADDITIONALLY THE PLASTIC ON THE TOP SCREW OF THE BRACKET WITH HANDLE WAS BROKEN WITH MISSING PARTICLES, IT WAS ESTABLISHED THE PARTICLES HAVE FALLEN OFF. IT WAS STATED THAT THE CRACKS HAVE BEEN ALSO FORMED ON THE FASTENINGS OF THE COVER, WHAT WAS CONFIRMED BY THE PHOTOGRAPHIC EVIDENCE. MOREOVER ON THE PHOTOGRAPHIC EVIDENCE THE PAINT CHIPPING ISSUE WAS FOUND. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 11TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. DURING ROUTINE PREVENTIVE MAINTENANCE PERFORMED ON THE DEVICE THE GETINGE TECHNICIAN DISCOVERED THE COVER MISSING FROM THE SPRING ARM. ADDITIONALLY THE PLASTIC ON THE TOP SCREW OF THE BRACKET WITH HANDLE WAS BROKEN WITH MISSING PARTICLES, IT WAS ESTABLISHED THE PARTICLES HAVE FALLEN OFF. IT WAS STATED THAT THE CRACKS HAVE BEEN ALSO FORMED ON THE FASTENINGS OF THE COVER, WHAT WAS CONFIRMED BY THE PHOTOGRAPHIC EVIDENCE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION. PREVIOUS H6 MEDICAL DEVICE ¿ PROBLEM CODE: MECHANICAL PROBLEM/DETACHMENT OF DEVICE OR DEVICE COMPONENT//2907; MATERIAL INTEGRITY PROBLEM/CRACK//1135; MATERIAL INTEGRITY PROBLEM/DEGRADED/PEELED/DELAMINATED/1454. CORRECTED H6 MEDICAL DEVICE ¿ PROBLEM CODE: MECHANICAL PROBLEM/DETACHMENT OF DEVICE OR DEVICE COMPONENT//2907; MATERIAL INTEGRITY PROBLEM/CRACK//1135. PREVIOUS H6 COMPONENT CODES: MECHANICAL/COVER//772; MECHANICAL/COATING MATERIAL//4768. CORRECTED H6 COMPONENT CODES: MECHANICAL/COVER//772.

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 ROUTINE PREVENTIVE MAINTENANCE PERFORMED ON THE DEVICE THE GETINGE TECHNICIAN DISCOVERED THE COVER MISSING FROM THE SPRING ARM. ADDITIONALLY THE PLASTIC ON THE TOP SCREW OF THE BRACKET WITH HANDLE WAS BROKEN WITH MISSING PARTICLES, IT WAS ESTABLISHED THE PARTICLES HAVE FALLEN OFF. IT WAS STATED THAT THE CRACKS HAVE BEEN ALSO FORMED ON THE FASTENINGS OF THE COVER, WHAT WAS CONFIRMED BY THE PHOTOGRAPHIC EVIDENCE. MOREOVER ON THE PHOTOGRAPHIC EVIDENCE THE PAINT CHIPPING ISSUE WAS FOUND. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION.