LUCEA 40 MOBILE

Additional Manufacturer Narrative

THE CORRECTION OF D4 VERSION OF MODEL AND CATALOG # AND B5 DESCRIBE EVENT AND PROBLEM DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 20TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40 MOBILE. BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER WAS CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE INFECTION. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 20TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40 MOBILE. IT WAS STATED THE PROTECTIVE COVER FOR THE SPRING ARM CONNECTION IS MISSING AND THE POWER CONTROL UNIT COVER IS DAMAGED. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER WAS CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE INFECTION. PREVIOUS D4 VERSION OF MODEL AND D4 CATALOG # ARDLCA309009A; CORRECTED D4 VERSION OF MODEL AND D4 CATALOG # ARD568601998. ACCORDING TO THE REPORTING TIMEFRAME WE WOULD LIKE TO PROVIDE THE INFORMATION ABOUT CURRENT STATUS OF THE ISSUE. PLEASE BE ADVISED THAT IT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

Description of Event or Problem

ON 20TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40 MOBILE. IT WAS STATED THE PROTECTIVE COVER FOR THE SPRING ARM CONNECTION IS MISSING AND THE POWER CONTROL UNIT COVER IS DAMAGED. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER WAS CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE INFECTION.

Additional Manufacturer Narrative

THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE SEPTEMBER 2016. THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN, H4 MANUFACTURE DATE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO. CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A. PREVIOUS H4 MANUFACTURE DATE: 2011-09-13. CORRECTED H4 MANUFACTURE DATE: 2012-09-13. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40 MOBILE. IT WAS STATED THE PROTECTIVE COVER FOR THE SPRING ARM CONNECTION IS MISSING AND THE POWER CONTROL UNIT COVER IS DAMAGED. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER WAS CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE INFECTION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. THERE IS NO INFORMATION IF THE CLAIMED DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. REGARDING CRACK HOUSING AT THE ROTATION STOP LOCATION THE MOST LIKELY ROOT CAUSE IS A VIOLENT ROTATION OF THE LIGHT HEAD. THE TEST RE11-052 PROVES THAT THE STOP RESISTS TO 50 STRONG ROTATIONS AND IS COMPLIANT TO THE STANDARD UL60601-1. FURTHERMORE, THESE CASES REMAIN ISOLATED. 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 RE-ADJUSTMENT OF THE SPRING ARM DURING THE MAINTENANCE OF MEDICAL DEVICE. THE YEARLY PREVENTIVE MAINTENANCE PROGRAM DOCUMENTED IN THE TECHNICAL MANUALS MENTIONS TO CHECK THE PRESENCE AND FIXING OF THE PLASTIC COVERS. THE CAP MUST BE REINSTALLED DURING INSTALLATION OR AFTER THE MAINTENANCE PROCEDURE. WE STRONGLY ADVISE 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. THE MOST LIKELY CAUSES OF DAMAGE TO THE POWER CONTROL UNIT COVER ARE IMPACT OR COLLISION (ABNORMAL USE). GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

Description of Event or Problem

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

Additional Manufacturer Narrative

(B)(6). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

Description of Event or Problem

ON 20TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40 MOBILE. BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER WAS CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE INFECTION.