BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMOPHARE SURGICAL AND EXAMINATION LIGHT

    MDR report key: 1190219 · Received October 7, 2008

    Report

    Report Number
    MW5008560
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 25, 2008
    Manufacturer
    BERCHTOLD CORPORATION
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FIVE OVERHEAD OPERATING ROOM LIGHTS WERE IDENTIFIED AS HAVING CRACKING PAINT CHIPS AT THE DOME OF THE LIGHT, CREATING THE POTENTIAL FOR FB IN OPERATIVE SITE OR INFECTION. WHEN COMPANY WAS NOTIFIED, THEY OFFERED TO SEND A REPAIR KIT (WHICH WE DID ACCEPT). THE OPERATING ROOM STAFF IS CONCERNED IF A REPAIR KIT IS AVAILABLE. WAS THIS A KNOWN DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMOPHARE SURGICAL AND EXAMINATION LIGHT OVERHEAD OPERATING ROOM LIGHTS FSY BERCHTOLD CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 *