BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AURORA

    MDR report key: 20075553 · Received August 27, 2024

    Report

    Report Number
    3006437518-2024-00013
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 15, 2024
    Report Date
    August 26, 2024
    Manufacturer
    DKK DAI-ICHI SHOMEI CO., LTD.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A LIGHTHEAD HAD A FAILED WELD THAT SHEERED OFF AND HIT A CLEANING STAFF MEMBER ON THE SHOULDER. THE LIGHT HEAD ULTIMATELY CRASHED TO THE FLOOR. THE CLEANING STAFF MEMBER WAS CHECKED OUT IN THE ER AT THE HOSPITAL AND FOUND TO BE UNHURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952819 AURORA CAMERA, SURGICAL, CEILING MOUNTED FSY DKK DAI-ICHI SHOMEI CO., LTD. AUT7TV

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown