LUCEA 40

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 HEADLIGHT'S COVER WAS DAMAGED WITH MISSING PARTICLES WHICH WAS CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE. ADDITIONALLY, SPRING ARM'S CAP WAS MISSING. THERE WAS NO INJURY REPORTED AND THE CIRCUMSTANCES OF THE MISSING CAP ARE UNKNOWN. HOWEVER, CONSIDERING THE WORSE CASE SCENARIO THE MISSING PART OR PARTICLES COULD DETACH FROM THE DEVICE AND FALL OFF DURING EXAMINATION WHICH MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.(B)(4). H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Additional Manufacturer Narrative

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 CAP, WHICH CONTRIBUTED TO THE EVENT. PROVIDED INFORMATION INDICATE THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. 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 CRACKS AND MISSING PARTICLES ON LUCEA 10/40 DEVICES IS MODERATE. A ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERTS AT MANUFACTURING SITE. BASED ON SOME INTERNAL TEST DONE BY MAQUET SAS (REF: CRE 12-085 FOR INSTANCE), ONLY ABNORMAL USE (VIOLENT COLLISIONS, EXCESSIVE PRESSURE¿) OR THE USE OF INCOMPATIBLE CLEANING PRODUCTS OR PROTOCOL, CAN DAMAGE THIS DEVICE AS REPORTED IN THIS COMPLAINT. TESTS PERFORMED BY GETINGE DID NOT LEAD TO CRACKS AS REPORTED IN THE COMPLAINT AT HAND. THE CRACKS DETECTED ON THE HANDLE INTERFACE AND TRANSPARENT COVER FIXING POINTS WERE PROBABLY CAUSED BY IMPROPER USE, COLLISIONS, INCOMPATIBLE CLEANING PRODUCTS OR PROTOCOL. TO PREVENT ANY INCIDENT THE LUCEA10/40 INSTRUCTION FOR USE 01701 EN12 MENTIONS TO CHECK THE INTEGRITY OF THE LIGHT HEADS DURING DAILY INSPECTION AND DESCRIBES HOW TO CLEAN AND DISINFECT THE LIGHT HEAD. THIS DOCUMENT INCLUDES SOME RECOMMENDED PRODUCTS AND SOME PROHIBITED PRODUCTS. IN ORDER TO AVOID MECHANICAL STRESSES APPLIED ON THE TRANSPARENT HOUSING DURING USE THE LUCEA10/40 INSTRUCTION FOR USE 01701 EN12 MENTIONS TO HANDLE THE LIGHT HEAD BY THE HANDLE. TO PREVENT ANY INCIDENT THE LUCEA10/40 INSTRUCTION FOR USE IFU 01701 MENTIONS TO CHECK THE INTEGRITY OF THE LIGHT HEADS DURING DAILY INSPECTION. FURTHERMORE, THE LUCEA10/40 INSTRUCTION FOR USE IFU 01701 EN12 EXPLAINS HOW TO CLEAN AND DISINFECT THE LIGHT HEADS. THIS DOCUMENT INCLUDES SOME RECOMMENDED PRODUCTS AND SOME PROHIBITED PRODUCTS. IN ORDER TO AVOID TORQUES APPLIED ON THE TRANSPARENT HOUSING DURING USE THE LUCEA10/40 INSTRUCTION FOR USE IFU 01701 EN12 MENTIONS TO HANDLE THE LIGHT HEAD BY THE HANDLE (IFU_LUCEA_10_40_01701EN12, PAGES 22-25, 30). 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.

Description of Event or Problem

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