BEUDAMED
    FDA Adverse Event Other Summary report: N

    9710055-2008-00020

    MDR report key: 1311712 · Received December 18, 2008

    Report

    Report Number
    9710055-2008-00020
    Event Type
    Other
    Date Received
    December 18, 2008
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ONE MAQUET REPRESENTATIVE VISITED THE HOSPITAL, AND EVALUATED THE LIGHT AND THE BOOT THAT FELL. THE TECHNICIAN FOUND THAT A PART OF THE PROTECTIVE RUBBER CAP OR "BOOT" HAD BEEN CUT AWAY DURING INSTALLATION. THE MISSING PIECE IS USED TO SECURE THE BOOT TO THE ASSEMBLY. DURING THE INVESTIGATION, MAQUET DISCOVERED THAT A LOW VOLTAGE VIDEO INTEGRATOR, NOT UNDER CONTRACT WITH MAQUET, MODIFIED THE CAP WHILE STRINGING VIDEO CABLES THROUGH THE LIGHT ARM. THE MAQUET X'TEN INSTALLATION MANUAL CLEARLY STATES THAT INSTALLERS ARE TO: "INSERT THE CABLES INSIDE THE BUMPER, SO AS TO ATTACH IT TO THE SUSPENSION AND PREVENT POTENTIAL FALLS." MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUEST S.A. PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FSY

    Patients

    Seq Age Sex Outcome Treatment
    1