BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2508879 · Received March 21, 2012

    Report

    Report Number
    2508879
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 10, 2012
    Report Date
    March 21, 2012
    Manufacturer
    HERAEUS INSTRUMENTS INC.
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY THE NURSE WENT TO MOVE THE LIGHT FOR BETTER VIEW AND THE LIGHT SNAPPED OUT OF CEILING AND HIT THE SURGEON ON THE HEAD AND LANDED ON THE PATIENT. AFTER REVIEW, IT APPARENTLY WAS LOOSENED BY WORKERS FROM MAQUET WHO ARE INSTALLING OR LIGHTS IN ERROR AND NOT RE-TIGHTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * OR OVERHEAD LIGHT FTD HERAEUS INSTRUMENTS INC. HANAULUX *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR