BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA LED®

    MDR report key: 16493882 · Received March 7, 2023

    Report

    Report Number
    9710055-2023-00177
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 20, 2023
    Report Date
    March 7, 2023
    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

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF D1 BRAND NAME, D2A PRODUCT CODE, D2B PRODUCT CODE DESCRIPTION, D4 CATALOG #, D4 UNIQUE IDENTIFIER (UDI) #, H3A DEVICE EVALUATED BY MFG, H3B DEVICE NOT EVAL PROVIDE CODE AND H3C IF OTHER PROVIDE CODE-EXPLAIN DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D1 BRAND NAME: LUCEA 50. CORRECTED D1 BRAND NAME: LUCEA LED®. PRODUCT D2A PRODUCT CODE: FTD. CORRECTED D2A PRODUCT CODE: FSY. PRODUCT D2B PRODUCT CODE DESCRIPTION. : LAMP, SURGICAL. CORRECTED D2B PRODUCT CODE DESCRIPTION. : LIGHT, SURGICAL, CEILING MOUNTED. PREVIOUS D4 CATALOG # ARDLCA209012A. CORRECTED D4 CATALOG # NONE. PREVIOUS D4 UNIQUE IDENTIFIER (UDI) #: N/A. CORRECTED D4 UNIQUE IDENTIFIER (UDI) #: (B)(4). PREVIOUS H3A DEVICE EVALUATED BY MFG: NO. CORRECTED H3A DEVICE EVALUATED BY MFG: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: NONE. PREVIOUS H3C IF OTHER PROVIDE CODE-EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE-EXPLAIN: NONE. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. AS IT WAS STATED, UPON THE DEVICE INSPECTION ONE OUT OF THE SIX FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE WERE LOOSE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS LOOSE SCREWS HOLDING THE DEVICE CONFIGURATION MAY LEAD TO THE DEVICE DETACHMENT FROM THE CEILING AND 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. THE CLAIMED DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. IN CASE OF LOOSENING, THE PROBABLE CAUSE OF LOOSENING CORRESPONDS TO AN IMPROPER INITIAL TIGHTENING DURING THE INSTALLATION OR A MAINTENANCE NOT IN ACCORDANCE WITH THE MANUFACTURER'S RECOMMENDATIONS. IN CASE OF RUPTURE, THE FAILURE OF THE SCREWS IS RELATED TO FATIGUE STRESSES DUE TO MODERATE SHEAR OVERLOAD. ALL FACIES HAVE A FATIGUE FAILURE ZONE MORE OR LESS EXTENSIVE. INITIATED AT THE BOTTOM OF THE THREAD, THE REPEATED LOW MECHANICAL STRESSES CAUSED THE BREAKAGE OF A FIRST SCREW. THE RUPTURE OF THE OTHER SCREWS CORRESPONDS TO PROGRESSIVE PROPAGATION OF THE SHEAR EFFECT. TO PREVENT ANY INCIDENT THE YEARLY PREVENTIVE MAINTENANCE PROGRAM, MENTIONS TO CHECK THE TIGHTENING OF FIXATION SCREWS ON THE SUSPENSION TUBE. IN APRIL 2019 GETINGE TRANSMITTED THE SERVICE BULLETIN 98A ON GETINGE ONLINE REMINDING TO CARRY OUT PREVENTIVE MAINTENANCE AND WEARING PARTS REPLACEMENT TO ENSURE THE DEVICE SAFETY, THE SERVICE BULLETIN 98A MENTIONS TO REPLACE THE SUSPENSION FIXING SCREWS EVERY 6 YEARS DURING THE PREVENTIVE MAINTENANCE. 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 20TH FEBRUARY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. AS IT WAS STATED, UPON THE DEVICE INSPECTION ONE OUT OF THE SIX FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE WERE LOOSE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS LOOSE SCREWS HOLDING THE DEVICE CONFIGURATION MAY LEAD TO THE DEVICE DETACHMENT FROM THE CEILING AND SERIOUS INJURY.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86072 LUCEA LED® LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARDLCA209012A 03700712400637

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown