BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILED7 SURGICAL LIGHT

    MDR report key: 22895897 · Received August 26, 2025

    Report

    Report Number
    3007143268-2025-00069
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    July 28, 2025
    Report Date
    October 24, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FSQ
    UDI-DI
    00887761968295
    PMA / PMN Number
    NA
    Removal / Correction Number
    3007143268-05/24/24-001-
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, H3, H6, H7, H9 AND H11. H11: A QUALIFIED BAXTER TECHNICIAN WAS SENT TO THE SITE AND INSPECTED THE LIGHTING SYSTEM AND FOUND THE LIGHTS TO BE PERFORMING ACCORDING TO PRODUCT SPECIFICATIONS. ALL FA-2024-035 INFORMATION IS NOW AVAILABLE AT THE CUSTOMER SITE. ON AUGUST 7, 2025, IT WAS CONFIRMED THAT THE DEFAULT SETTING FOR LIGHT INTENSITY WHEN SWITCHING ON THE LIGHTS IS 50%. ON AUGUST 25, 2025, THE EXCHANGE OF THE IPAD WAS REPLACED. IN SUMMARY, DUE TO THE OVERLAP OF LIGHT FIELDS WITH HIGH INTENSITY SETTINGS WITHOUT THE USE OF AUTOFOCUS, THE ILLUMINATION INTENSITY IN THE SURGICAL AREA WAS INCREASED. THIS CAN OCCUR WITH 3 LIGHTS, BUT ALSO WITH 2 LIGHTS WITH HIGH INTENSITY SETTINGS. THE CUSTOMER HAS BEEN EDUCATED ON THE CORRECT USE OF THE DEVICE. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ILED 7 CEILING DUO BURNED A PATIENT. DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SURGICAL TEAM FOUND THE PATIENT¿S SKIN WAS ¿LIKE PEELING AT BACK OF THE PATIENT¿ AND TEMPERATURE WHERE THE LIGHT WAS FOCUSED ON THE PATIENT¿S BACK WAS HOTTER COMPARED TO THE OTHER PARTS OF THE PATIENT¿S BODY. THE PATIENT WAS TREATED WITH COLD FLUIDS APPLIED TO THE AFFECTED AREA. THE BIOMEDICAL DEPARTMENT DID AN INVESTIGATION BY FOCUSING THE LIGHT ON ONE SPOT AND FOUND THAT THE AREA WHERE IT WAS FOCUSED ON WAS HOT AND REACHED A TEMPERATURE OF 43 DEGREES CELSIUS. THE LIGHT DEFAULT NORMAL SETTINGS ARE 50%; HOWEVER, THE OPERATING ROOM TEAM CAN INCREASE THEM DURING THE PROCEDURE IF NEEDED. THE BAXTER TECHNICIAN CHECKED THE SOFTWARE OF THE LIGHT AND FOUND THAT ALL ARE UP TO DATE. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406994 ILED7 SURGICAL LIGHT LIGHT, SURGICAL, INSTRUMENT FSQ BAXTER HEALTHCARE CORPORATION 4068210 NA 00887761968295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown