BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET POWERLED II

    MDR report key: 20566700 · Received October 30, 2024

    Report

    Report Number
    9710055-2024-0000581
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Report Date
    October 30, 2024
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    UDI-DI
    03700712406615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SITE NAME: (B)(6). EVENT SITE TELEPHONE: (B)(6). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORTER WAS GETINGE EMPLOYEE. IT WAS CONFIRMED THAT THE ISSUE REPORTED UNDER MANUFACTURER¿S REFERENCE NUMBER: (B)(4) (REPORT NUMBER: 9710055-2024-0000581) IS A DUPLICATE OF THE ISSUE REPORTED UNDER MANUFACTURER¿S REFERENCE NUMBER: (B)(4) (REPORT NUMBER: 9710055-2024-00206). THEREFORE, THE ISSUE IS EVALUATED UNDER MANUFACTURER¿S REFERENCE NUMBER: (B)(4); (REPORT NUMBER: 9710055-2024-00206).

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE PAINT AND LABEL WERE CHIPPING FROM THE SUSPENSION ARM. 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
    1001017 MAQUET POWERLED II LAMP, SURGICAL FTD MAQUET SAS ARDPWT209142A 03700712406615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown