BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGENIEUX AX4

    MDR report key: 24978626 · Received April 24, 2026

    Report

    Report Number
    9710055-2026-0000078
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 24, 2026
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. EVENT SITE NAME: VIETMEDICAL DISTRIBUTION JSC EVENT SITE TELEPHONE: (B)(6).

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - ANGENIEUX AX4. THE DESIGNATED COMPLAINT UNIT EMPLOYEE IDENTIFIED PAINT CHIPPING PRESENCE ON THE SUSPENSION ARM BASED ON PHOTOGRAPHIC EVIDENCE. NO INJURIES HAVE BEEN REPORTED, HOWEVER WE DECIDED TO REPORT THIS ISSUE OUT OF AN ABUNDANCE OF CAUTION, AS ANY PARTICLES FALLING INTO THE STERILE FIELD OR DURING A PROCEDURE COULD CAUSE CONTAMINATION IN THE EVENT OF RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473976 ANGENIEUX AX4 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD567205995

    Patients

    Seq Age Sex Outcome Treatment
    1