BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AURORA 4

    MDR report key: 9969874 · Received April 16, 2020

    Report

    Report Number
    3006437518-2020-00001
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Date of Event
    November 19, 2019
    Report Date
    April 16, 2020
    Manufacturer
    DKK DAI-ICHI SHOMEI CO., LTD.
    Product Code
    KQM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CAMERA INSTALLED INTO THE AUA5TV LIGHT HEAD FELL ONTO THE PATIENT. THE OPERATING ROOM NURSE MANAGER ASSESSED THE PATIENT AND CONFIRMED NO INJURY AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434066 AURORA 4 CAMERA, SURGICAL AND ACCESSORIES KQM DKK DAI-ICHI SHOMEI CO., LTD. AUA5TV

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR