BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 3201869 · Received June 26, 2013

    Report

    Report Number
    3008355164-2013-00156
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MAQUET SAS- ORLEANS- FRANCE
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED TO MAQUET THAT A LIGHT HEAD DISENGAGED FROM THE SPRING ARM AND HIT THE FLOOR. EVENT HAPPENED WHILE THE OPERATING ROOM WAS BEING PREPARED FOR SURGERY. PROCEDURE WAS NOT DELAYED. NO INJURIES WERE REPORTED. (B)(4). MFR NUMBER: 9710055-2013-00026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289700 MAQUET SAS NA FSY MAQUET SAS- ORLEANS- FRANCE XTEN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA