BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET EQUIPMENT

    MDR report key: 23876021 · Received December 23, 2025

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    Report

    Report Number
    9710055-2025-0000315
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 2, 2025
    Report Date
    December 23, 2025
    Manufacturer
    MAQUET SAS
    Product Code
    FXR
    UDI-DI
    03700712416096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHT - EQT. AS IT WAS STATED, SPRING ARM COVER DETACHED FROM THE DEVICE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. PROVIDED INFORMATION INDICATE IF UPON THE EVENT OCCURRENCE, THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERT AT MANUFACTURER¿S, THE ANALYSIS IS FOLLOWING. DURING DAILY CHECK OF THE XHS0 SCREEN HOLDER, IT WAS DISCOVERED THAT THE SIDE COVER OF THE ARD567801151 SPRING ARM WAS DETACHED. NO BROKEN PARTS OR ANOMALIES IN THE ASSEMBLY WERE REPORTED. NO FALL WAS REPORTED. THE CAUSE OF THE DETACHMENT IS PROBABLY A GRADUAL LOOSENING OR THE ABSENCE OF ONE OF THE COVER FIXING SCREWS. BASED ON THAT THE SPECIFIC ROOT CAUSE CANNOT BE DETERMINED. TO PREVENT ANY INCIDENT THE INSTRUCTION FOR USE IFU 01821 MENTIONS TO CHECK, DURING DAILY VISUAL AND FUNCTIONAL INSPECTIONS, THAT THE SPRING ARM COVERS ARE IN THE PROPER POSITION AND IN GOOD CONDITION. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHT - EQT. AS IT WAS STATED, SPRING ARM COVER DETACHED FROM THE DEVICE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057216 MAQUET EQUIPMENT HOLDER, CAMERA, SURGICAL FXR MAQUET SAS ARDSAT239019A 03700712416096

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown