BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA LED®

    MDR report key: 19641451 · Received July 1, 2024

    Report

    Report Number
    9710055-2024-00390
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 18, 2024
    Report Date
    July 1, 2024
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    UDI-DI
    03700712400637
    PMA / PMN Number
    K113679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER WAS GETINGE TECHNICIAN. THE CORRECTION OF D1 BRAND NAME, D2 PRODUCT CODE, D4 VERSION OF MODEL#: D4 CATALOG#: D4 UNIQUE IDENTIFIER (UDI)#, FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D1 BRAND NAME: LUCEA 50/100. CORRECTED D1 BRAND NAME: LUCEA LED®. PREVIOUS D2A PRODUCT CODE. FTD. CORRECTED D2A PRODUCT CODE. FSY. PREVIOUS D4 VERSION OF MODEL#: ARD568604998. CORRECTED D4 VERSION OF MODEL#: ARDLCA209012A. PREVIOUS D4 CATALOG#: ARD568604998. CORRECTED D4 CATALOG#: NONE. PREVIOUS D4 UNIQUE IDENTIFIER (UDI)#: N/A. CORRECTED D4 UNIQUE IDENTIFIER (UDI)#: (B)(4). GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS, LUCEA 50. IT WAS STATED THE CAP AND SCREW WERE 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. BASED ON THE INFORMATION COLLECTED, 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. THE CLAIMED DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. NO ROOT CAUSE COULD BE DETERMINED WITH THE ELEMENTS PROVIDED. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ON 18TH JUNE, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. IT WAS STATED THE CAP AND SCREW WERE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815550 LUCEA LED® LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARDLCA209012A 03700712400637

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown