LUCEA 40
Received May 16, 2023 · Event occurred Apr 24, 2023
Report 9710055-2023-00362 · MDR key 16936916
Device
Generic name
Device, Medical Examination, Ac Powered
Manufacturer
Maquet SasModel number
ARD568601999Catalog number
ARD568601999
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED, THE HEADLIGHT DETACHED AND WAS HANGING ON THE CABLES CREATING THE RISK OF FALL. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION MAY CAUSE SERIOUS INJURY. 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. 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 STANDART UL60601-1. FURTHERMORE THESE CASES REMAIN ISOLATED. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME. THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN 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. THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE SEPTEMBER 2016.
Description of Event or Problem
MANUFACTURER'S REFERENCE NUMBER (B)(4).
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 24TH APRIL 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED, THE HEADLIGHT DETACHED AND WAS HANGING ON THE CABLES CREATING THE RISK OF FALL. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION MAY CAUSE SERIOUS INJURY.