BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DCI

    MDR report key: 23711234 · Received December 3, 2025

    Report

    Report Number
    1000523896-2025-00001
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 3, 2025
    Manufacturer
    DCI INTERNATIONAL
    Product Code
    NRU
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL ON-GOING.

    Description of Event or Problem · 0

    DENTAL CHAIR HAD UNINTENDED MOVEMENT WITH PATIENT IN CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2853586 DCI SERIES 5 DENTAL CHAIR NRU DCI INTERNATIONAL C5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention