BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA LED®

    MDR report key: 19981430 · Received August 14, 2024

    Report

    Report Number
    9710055-2024-00473
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 14, 2024
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    UDI-DI
    03700712400637
    PMA / PMN Number
    K113679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER: PERSON IN CHARGE #. EVENT SITE TELEPHONE: (B)(6). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA LED®. IT WAS STATED THE COVER'S SCREW WAS MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, 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 AN INFORMATION GATHERED, DEFECTIVE PART (CAP SPRING ARM BLUE 30 NEW RAL9016 - ARD569010102) WAS REPLACED. 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 DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT UPON THE EVENT OCCURRENCE. ACCORDING TO THE INFORMATION GATHERED, THE ISSUE WAS DISCOVERED DURING PREVENTIVE MAINTENANCE. AS STATED BY SUBJECT MATTER EXPERT AT MAQUET SAS, 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 READJUSTMENT OF THE SPRING ARM DURING THE MAINTENANCE OF MEDICAL DEVICE. THE YEARLY PREVENTIVE MAINTENANCE PROGRAM DOCUMENTED IN THE TECHNICAL MANUAL FOR LUCEA 10/40 (0170201 1K) ON PAGE 10 MENTIONS TO CHECK THE FIXING OF ALL CAPS. THE CAP MUST BE REINSTALLED DURING INSTALLATION OR AFTER THE MAINTENANCE PROCEDURE. MAQUET SAS STRONGLY ADVISES 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 (BLUE 30 / LUCEA 40-50: ARD569010102). GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    ON 1ST AUGUST, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA LED®. IT WAS STATED THE COVER'S SCREW WAS MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263151 LUCEA LED® LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARDLCA209012A 03700712400637

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown