BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 977329 · Received April 5, 2007

    Report

    Report Number
    9710055-2007-00011
    Event Type
    Other
    Date Received
    April 5, 2007
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAST MAINTENANCE WAS PERFORMED ON THIS EQUIPMENT ON JANUARY 16, 2007. IT WAS DETERMINED THE RUBBER END CAP HAD NOT BEEN SEATED PROPERLY AFTER THIS MAINTENANCE VISIT. THE CUSTOMER USED THE LIGHT WITHOUT NOTICING THE RUBBER CAP WAS LOOSE. AFTER THIS INCIDENT, THE RUBBER END CAP WAS REINSTALLED AND SEATED ACCORDING TO DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * FSY MAQUET S.A. * *

    Patients

    Seq Age Sex Outcome Treatment
    1