BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA 50/100

    MDR report key: 19960276 · Received August 12, 2024

    Report

    Report Number
    9710055-2024-00467
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 12, 2024
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SITE NAME: CLINIQUE (B)(6). INITIAL REPORTER WAS BIOMEDICAL TECHNICIAN. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 30TH JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. IT WAS STATED THE COVER WAS MISSING FROM DEVICE. 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 30TH JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. IT WAS STATED THE CAP FROM SUSPENSION ARM 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. THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE AS THIS MEDICAL DEVICE/MODEL WAS MARKETED AND/OR DISCONTINUED IN US BEFORE THE UDI REQUIREMENT BECAME MANDATORY. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. IT WAS STATED THE CAP FROM SUSPENSION ARM 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. 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. ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERT AT MANUFACTURER¿S. THE ANALYSIS IS FOLLOWING: IT IS NORMALLY HELD BY 2 SCREWS AND THE FACT THAT IT IS COMPLETELY MISSING HAS ONLY ONE CAUSE: IT HAS BEEN REMOVED BY A TECHNICIAN AND NOT FITTED BACK DURING MAINTENANCE PROCEDURE OR NOT INSTALLED AT ALL SINCE THE BEGINNING WHICH IS VERY UNLIKELY REGARDING THE INSTALLATION DATE (2015). IN ANY CASE IT IS AN OVERSIGHT. 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 · 0

    ON 30TH JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. IT WAS STATED THE COVER WAS MISSING FROM DEVICE. 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.

    Description of Event or Problem · 0

    ON 30TH JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. IT WAS STATED THE CAP FROM SUSPENSION ARM 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
    1725075 LUCEA 50/100 LAMP, SURGICAL FTD MAQUET SAS ARD568604998

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown