BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAULUX

    MDR report key: 981249 · Received November 14, 2007

    Report

    Report Number
    3004147784-2007-00029
    Event Type
    Malfunction
    Date Received
    November 14, 2007
    Date of Event
    October 11, 2007
    Report Date
    October 15, 2007
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    BR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON A HLX 2000 SURGICAL LIGHT CONFIGURATION, ONE OF THE LENSES DROPPED FROM THE LIGHTHEAD DURING A SURGICAL PROCEDURE. THE CUSTOMER DID NOT REPORT ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANAULUX FSY FSY MAQUET S.A. HLX 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *