BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAULUX

    MDR report key: 17235 · Received October 27, 1994

    Report

    Report Number
    MW1003837
    Event Type
    Malfunction
    Date Received
    October 27, 1994
    Date of Event
    October 13, 1994
    Report Date
    October 17, 1994
    Manufacturer
    HERAEUS SURGICAL, INC.
    Product Code
    FQP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGICAL LIGHT SEPARATED FROM MOUNTING PLATE AND DROPPED FROM CEILING PLATE AND DROPPED FROM CEILING. ELECTRICAL WIRES HELD AND PREVENTED LIGHT FROM DROPPING ALL THE WAY. LIGHT ARM WITH LIGHT HIT GUERNEY AND OPERATING MICROSCOPE. NO INJURY TO PT OR OPERATING ROOM PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANAULUX OPERATING ROOM SURGICAL LIGHT FQP HERAEUS SURGICAL, INC. 2003/4

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Other