LUCEA 40

Description of Event or Problem

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

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED, THERE WAS A CRACK IN THE PLASTIC BETWEEN THE FORK AND THE LAMP HOLDER. BASED ON THE PROVIDED PHOTOGRAPHIC EVIDENCE, THE CRACKED COVER WITH MISSING PARTICLES AND HEADLIGHT DISCONNECTED FROM THE FORK WHICH WAS HANGING ON THE WIRES WERE IDENTIFIED. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OR SERIOUS INJURY OF THE PATIENT. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATIONAL LIGHT DID NOT MEET ITS SPECIFICATION, DUE TO HEADLIGHT CRACKED WITH MISSING PARTICLES AND HEADLIGHT DETACHMENT FROM THE FORK, WHICH COULD BE CONSIDERED AS TECHNICAL DEFICIENCY, AND IN THIS WAY THE DEVICE CONTRIBUTED TO THE EVENT. PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE, THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, IT WAS CONFIRMED THAT IN THE LAST 5 YEARS, REGISTERED FOR THE ISSUE OF HEADLIGHT CRACKED WITH MISSING PARTICLES AND HEADLIGHT DETACHMENT FROM THE FORK, THERE IS NO EVENT WHICH LED TO THE SERIOUS INJURY. COMPARING THE NUMBER OF CLAIMED DEVICES TO NUMBER OF SOLD DEVICES WORLDWIDE, WE CAN ASSUME THAT THE FAILURE RATIO FOR THE ISSUE OF CRACKED HEADLIGHT WITH MISSING PARTICLES IS MODERATE, AND FOR THE HEADLIGHT DETACHMENT IS VERY LOW. AS STATED BY SUBJECT MATTER EXPERT AT THE MANUFACTURING SITE, THE HEADLIGHT IS CRACKED DUE TO A VIOLENT ROTATION OF THE LIGHT HEAD. IT CAN BE NOTICED THAT THE HOUSING IS SPLIT AT THE STOP LOCATION. THIS STOP IS USED TO LIMIT THE ROTATION OF THE LIGHT TO 290°. THE INSERTION OF THE STOP IN THE HOUSING (MADE OF ABS-PC) IS PERFORMED BY ULTRASONIC PROCESS. IT MEANS THAT IT IS STRAIN-FREE AFTER ASSEMBLY. THEN, THE ONLY POSSIBLE ROOT CAUSE TO SPLIT THE HOUSING AT THIS LOCATION IS A VIOLENT SHOCK DURING ROTATION. REGARDING THIS STOP ROTATION SOME TESTS HAVE BEEN DONE IN 2011 AT MAQUET SAS. THE TEST REPORT RE11-052 MENTIONS THAT THE LIGHT LUCEA 40 IS COMPLIANT TO THE STANDARD UL60601-1. INDEED, TESTS HAVE BEEN PERFORMED ON 2 LIGHT HEADS WITH 50 STRONG ROTATIONS ON BOTH DIRECTION (CLOCKWISE AND COUNTERCLOCKWISE) AND NO CRACKS WERE FOUND. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

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 OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED, THERE WAS A CRACK IN THE PLASTIC BETWEEN THE FORK AND THE LAMP HOLDER. BASED ON THE PROVIDED PHOTOGRAPHIC EVIDENCE, THE CRACKED COVER WITH MISSING PARTICLES AND HEADLIGHT DISCONNECTED FROM THE FORK WHICH WAS HANGING ON THE WIRES WERE IDENTIFIED. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OR SERIOUS INJURY OF THE PATIENT.