BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA 50/100

    MDR report key: 19813971 · Received July 24, 2024

    Report

    Report Number
    9710055-2024-00431
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Report Date
    July 24, 2024
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER WAS (B)(4). THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM, H6 INVESTIGATION FINDINGS, H6 INVESTIGATION CONCLUSIONS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 18TH JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50 MOBILE. IT WAS STATED THE SPRING ARM COVER WAS MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 18TH JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50 MOBILE. IT WAS STATED THE SPRING ARM COVER WAS MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. FURTHER INFORMATION PROVIDED BY GETINGE EMPLOYEE INDICATED THAT NOTHING FELL FROM DEVICE. THE COVER WAS LOST DURING MOVEMENT OF EQUIPMENT IN THE HOSPITAL AND WAS NOT USED WITHOUT COVER. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THERE WAS NO INDICATION OF MISSING PARTS THAT COULD FALL OFF INTO STERILE FIELD, WHICH WAS INITIALLY CONSIDERED. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. PREVIOUS H6 INVESTIGATION FINDINGS: RESULTS PENDING COMPLETION OF INVESTIGATION///3233. CORRECTED H6 INVESTIGATION FINDINGS: NONE. PREVIOUS H6 INVESTIGATION CONCLUSIONS: CONCLUSION NOT YET AVAILABLE//11. CORRECTED H6 INVESTIGATION CONCLUSIONS: CAUSE TRACED TO USER//19. INITIALLY PROVIDED INFORMATION WAS POINTING TO MISSING SPRING ARM COVER. THE ISSUE IS CONSIDERED AS SAFETY RELATED AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. ACCORDING TO ADDITIONAL CLARIFICATION PROVIDED BY THE GETINGE TECHNICIAN, THE INITIAL INFORMATION WAS INCORRECT. IT WAS DETERMINED THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED AS THERE WAS NO INDICATION OF MISSING PARTS THAT COULD FALL OFF INTO STERILE FIELD. THE INVESTIGATION WAS PERFORMED. THE INVESTIGATED SCENARIOS DID NOT CAUSE RISK TO HUMAN LIFE. THE REVIEW OF THE CUSTOMER PRODUCT COMPLAINTS, RELATED TO INVESTIGATED ISSUE IN TIME, SHOWS THAT THERE IS NO REGULAR INCOME. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS. NO APPARENT REASON WAS IDENTIFIED FOR SUGGESTING TO OPEN A CAPA OR EVALUATION FOR THE NEED OF ANOTHER ACTION IN THE MARKET.

    Additional Manufacturer Narrative · 0

    EVENT SITE NAME: 200151-08 - (B)(6). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON 18TH JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50 MOBILE. IT WAS STATED THE SPRING ARM COVER WAS MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIUS INJURY. FURTHER INFORMATION PROVIDED BY GETINGE EMPLOYEE INDICATED THAT NOTHING FELL FROM DEVICE. THE COVER WAS LOST DURING MOVEMENT OF EQUIPMENT IN THE HOSPITAL AND WAS NOT USED WITHOUT COVER. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THERE WAS NO INDICATION OF MISSING PARTS THAT COULD FALL OFF INTO STERILE FIELD, WHICH WAS INITIALLY CONSIDERED. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.

    Description of Event or Problem · 0

    ON 18TH JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50 MOBILE. IT WAS STATED THE SPRING ARM COVER WAS MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364572 LUCEA 50/100 LAMP, SURGICAL FTD MAQUET SAS ARDLCA309005A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown