BEUDAMED
    FDA Adverse Event Other Summary report: N

    CASTLE

    MDR report key: 726589 · Received June 13, 2006

    Report

    Report Number
    3019090-2006-00001
    Event Type
    Other
    Date Received
    June 13, 2006
    Report Date
    April 6, 2006
    Manufacturer
    GETINGE USA, INC-F.K.A GETINGE/CASTLE
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BREAK MAY HAVE BEEN DUE TO METAL FATIGUE. PART WAS NOT RETURNED FOR EVALUATION. A NEW YOKE HAS BEEN INSTALLED, FUNCTIONS TESTED AND RETURNED TO END USER.

    Description of Event or Problem · 1

    PATIENT WAS SEDATED AND ANESTHESIOLOGIST WAS IN THE PROCESS FO POSITIONING THE LIGHT WHEN THE YOKE BROKE OFF AND FELL. THE LIGHTHEAD MISSED THE PATIENT AND WAS DANGLING BESIDE THE SUGICAL TABLE SUPPORTED BY ITS POWER SUPPLY CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTLE SURGICAL LIGHT FSY GETINGE USA, INC-F.K.A GETINGE/CASTLE GCL 550 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other