BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA 50/100

    MDR report key: 16443969 · Received February 27, 2023

    Report

    Report Number
    9710055-2023-00135
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    February 3, 2023
    Report Date
    February 27, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO. CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50/100. IT WAS STATED THE COVER HAD COME OFF. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO THE EVENT. THERE IS NO INFORMATION IF THE CLAIMED DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. THE INCIDENT IS DUE TO INAPPROPRIATE USE. A SHOCK WITH ANOTHER DEVICE IS THE MOST PROBABLE ROOT CAUSE OF THIS INCIDENT. IF THE DESCRIBED FAILURE OCCURS, THE USER CAN VISUALLY DETECT IT DURING THE DAILY CHECKS TO BE PERFORMED PRIOR TO EACH USE, OR DURING PREVENTIVE MAINTENANCE. IN THIS CASE, THE USER WOULD CONTACT A GETINGE REPRESENTATIVE TO REPLACE THE DEFECTIVE COVERS OF THE AFFECTED DEVICE. TO PREVENT ANY INCIDENT THE LUCEA 50-100 USER MANUAL MENTIONS: ¿CHECK THE LIGHT HEADS FOR CHIPPED PAINT, IMPACT MARKS AND ANY OTHER DAMAGE¿ DURING THE DAILY INSPECTIONS. GETINGE SHALL CONTINUE TO MONITOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    ON 3RD FEBRUARY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50/100. IT WAS STATED THE COVER HAD COME OFF. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES 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
    409919 LUCEA 50/100 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown