BEUDAMED
    FDA Adverse Event Other Summary report: N

    9710055-2008-00010

    MDR report key: 1241547 · Received September 5, 2008

    Report

    Report Number
    9710055-2008-00010
    Event Type
    Other
    Date Received
    September 5, 2008
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET REP VISITED THE HOSPITAL, AND EVALUATED THE LIGHT AND THE PROTECTIVE RUBBER CAP THAT FELL. HE 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 INC DISCOVERED THAT A THIRD PARTY CONTRACTOR MODIFIED THE CAP WHILE STRINGING VIDEO CABLES THROUGH THE LIGHT ARM. THE MAQUET XTEN INSTALLATION MANUAL CLEARLY STATES THAT INSTALLERS ARE TO: "INSERT THE CABLES INSIDE THE BUMBPER, SO AS TO ATTACH IT TO THE SUSPENSION AND PREVENT POTENTIAL FALLS." MAQUET INC IS ASSISTING THE CUSTOMER IN RESOLVING THIS ISSUE IN ORDER TO PREVENT FURTHER OCCURRENCES. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET 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