BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASTLE

    MDR report key: 474321 · Received July 25, 2003

    Report

    Report Number
    3019090-2003-00001
    Event Type
    Malfunction
    Date Received
    July 25, 2003
    Date of Event
    May 5, 2003
    Report Date
    June 28, 2003
    Manufacturer
    GETINGE USA, INC
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE LAMPHEAD CAME UNATTACHED FROM ITS CONTERBALANCE ARM AND MADE CONTACT WITH THE DR'S. HEAD. NO INJURY WAS RESULTED FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTLE MINOR SURGICAL LIGHT FSY GETINGE USA, INC 2410C *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other