BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 3111031 · Received April 8, 2013

    Report

    Report Number
    9710055-2013-00016
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Removal / Correction Number
    Z-0182/188-2010
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A MAINTENANCE TECHNICIAN AUTHORIZED BY MAQUET VISITED THE HOSPITAL AND FOUND THE FRONT PIVOT OF THE SPRING ARM BROKEN. THE FST REPLACED THE SPRING ARM WITH A NEW ONE AND INSPECTED ALL OTHER MAQUET LIGHTS OF THIS DESIGN AT THE FACILITY. AN ADD'L FISSURED WELD SEAM WAS FOUND AT THE SITE. A REPLACEMENT SPRING ARM HAS BEEN PURCHASED AND WILL BE REPLACED UPON DELIVERY. THIS MALFUNCTION WAS PREVIOUSLY ADDRESSED IN THE USA THROUGH THE DEVICE CORRECTION. (B)(4). MAQUET SAS PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144740 MAQUET SAS FSY MAQUET S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1