BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHROMOPHARE D540 SURGICAL LIGHT

    MDR report key: 780644 · Received November 6, 2006

    Report

    Report Number
    1220685-2006-00003
    Event Type
    Other
    Date Received
    November 6, 2006
    Date of Event
    October 9, 2006
    Report Date
    November 6, 2006
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A FEMALE NURSE IN THE TRAUMA ROOM WAS POSITIONING A D540 LIGHT OVER THE SURGICAL TABLE WHEN THE LIGHT HEAD AND SPRING ARM DETACHED FROM THE SUSPENSION ARM AND FELL TO THE GROUND. THE NURSE WAS STRUCK BY THE LIGHT HEAD, BUT IT IS UNK WHAT THE EXTENT OF HER INJURIES WERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMOPHARE D540 SURGICAL LIGHT SURGICAL LIGHT FSY BERCHTOLD CORP. D540 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN