BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASTLE

    MDR report key: 1581022 · Received January 15, 2010

    Report

    Report Number
    1225700-2010-00005
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Report Date
    December 21, 2009
    Manufacturer
    MAQUET, INC. (F.K.A. GETINGEUSA)
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHT INVOLVED IN THIS INCIDENT WAS MANUFACTURED BY CASTLE IN THE 1983-1987 TIME FRAME. THESE LIGHTS WERE PRODUCED BY CASTLE PRIOR TO THE PURCHASE OF THE COMPANY BY (B)(4) IN THE 2000-2001 TIME FRAME. AT THAT TIME THE MANUFACTURING OF THE CASTLE LIGHTS WAS STOPPED. CURRENTLY, THE MANUFACTURING SITE IN CHARLESTON IS IN THE PROCESS OF BEING CLOSED DOWN AND THE PRODUCT COMPLAINTS FOR CHARLESTON PRODUCT GOING FORWARD ARE BEING PROCESSED BY THE MAQUET INC. (B)(4) SALES AND SERVICE UNIT (FIRST IMPORTER) IN (B)(4). MAQUET INC. IS PRESENTLY ATTEMPTING TO CONTACT MR. (B)(4) TO ARRANGE FOR A SERVICE VISIT TO EXAMINE THE LIGHT AND GATHER ADDITIONAL DETAILS. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    MAQUET INC. RECEIVED E-MAIL REQUEST FOR PARTS TO REPAIR A BROKEN CASTLE LIGHT. IN THE E-MAIL, IT WAS REPORTED THAT THE ARM OF THE LIGHT HAD SNAPPED AND WAS HANGING FROM THE BEARING POST. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTLE FSY MAQUET, INC. (F.K.A. GETINGEUSA) CASTLE 2420C

    Patients

    Seq Age Sex Outcome Treatment
    1