BEUDAMED
    FDA Adverse Event Other Summary report: N

    9710055-2008-00015

    MDR report key: 1239309 · Received October 13, 2008

    Report

    Report Number
    9710055-2008-00015
    Event Type
    Other
    Date Received
    October 13, 2008
    Product Code
    FSY
    PMA / PMN Number
    K982063
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET REP VISITED THE HOSP AND EVALUATED THE DEVICE. THE COVER THAT FELL IS CLIPPED ON THE SPRING ARM. HE FOUND THAT THE COVER THAT FELL WAS WORN OUT, MAKING IT NOT FIRMLY ATTACHED TO THE SPRING ARM. THIS HOSPITAL IS NOT UNDER PREVENTIVE MAINTENACE CONTRACT WITH MAQUET. MAQUET REP ON SITE EVALUATED AND ORDERED REPLACEMENT PARTS. 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