BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED II

    MDR report key: 23775744 · Received December 11, 2025

    Report

    Report Number
    9710055-2025-0000306
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 27, 2025
    Report Date
    December 11, 2025
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE AS THIS MEDICAL DEVICE/MODEL WAS MARKETED AND/OR DISCONTINUED IN US BEFORE THE UDI REQUIREMENT BECAME MANDATORY.

    Additional Manufacturer Narrative · 0

    IT APPEARED THAT THE ISSUE REPORTED UNDER MANUFACTURER¿S REFERENCE NUMBER: (B)(4). (REPORT NUMBER: 9710055-2025-0000306) IS A DUPLICATE OF THE ISSUE REPORTED UNDER MANUFACTURER¿S REFERENCE NUMBER: (B)(4) (REPORT NUMBER: 9710055-2025-0000305). THEREFORE, THE ISSUE IS EVALUATED UNDER MANUFACTURER¿S REFERENCE NUMBER: (B)(4) (REPORT NUMBER: 9710055-2025-0000305).

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE PAINT IS PEELING OFF AROUND THE CONTROL PANEL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PAINT 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
    567977 POWERLED II LAMP, SURGICAL FTD MAQUET SAS ARD569202911

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown