LUCEA 40

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 24TH MAY, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE BUTTON FELL OUT FROM HEADLIGHT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DETACHMENT OF PART OR PARTICLES MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.

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 40. AS IT WAS CLAIMED BY THE CUSTOMER, THE ON/OFF BUTTON FELL OUT FROM THE HEADLIGHT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN AN ABUNDANCE OF CAUTION AS ANY DETACHMENT OF PART OR PARTICLES MAY LEAD TO POTENTIAL INFECTION OF A PATIENT. ACCORDING TO THE INFORMATION PROVIDED BY THE SERVICE UNIT, THE DEVICE HAS BEEN REPAIRED BY THE REPLACEMENT OF A FAULTY PART - BLUE/LCA - SWITCH 1 POLE 250 V 10 A. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATION LIGHT DID NOT MEET ITS SPECIFICATION, SINCE DETACHMENT OF A BUTTON FROM THE HEADLIGHT COULD BE CONSIDERED AS A 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 DIAGNOSIS. 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. A ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERTS AND CONCLUDED THAT THE CAUSE OF THE DETACHMENT OF THE ON/OFF BUTTON IS PROBABLY A MECHANICAL SHOCK. TO PREVENT ANY INCIDENTS, THE INSTRUCTION FOR USE (LUCEA 10-40 IFU 01701 REV. 11, PAGES 16, 21) OPERATING INSTRUCTIONS MENTION "THIS LIGHT MUST NOT BE USED IF IT IS DAMAGED" AND TO "CHECK THAT THE DEVICE HAS NOT SUFFERED ANY IMPACT DAMAGE" DURING DAILY CHECKS BEFORE USE. THE IFU (LUCEA 10-40 IFU 01701 REV. 11, PAGE 7) MENTIONS THAT THE LUCEA 40 IS A DIAGNOSTIC LAMP INTENDED FOR LOCAL ILLUMINATION OF THE PATIENT'S BODY TO FACILITATE DIAGNOSTIC OR TREATMENT PROCEDURES THAT CAN BE DISCONTINUED WITHOUT RISK TO THE PATIENT IN THE EVENT OF LAMP FAILURE. IT IS NOT INTENDED FOR USE IN THE OPERATING ROOM. 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.