BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 980215 · Received August 21, 2007

    Report

    Report Number
    9710055-2007-00021
    Event Type
    Other
    Date Received
    August 21, 2007
    Manufacturer
    MAQUET S.A.
    Product Code
    BYX
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED ON SITE, HIGHLIGHTED: A PLASTIC SCREW WAS FOUND TO BE BROKEN. THE SCREW IS USED TO RETAIN THE HALF COVER PIECE IN PLACE. THE MAINTENANCE PROGRAM INDICATES ''ANY COVER COMPONENTS SHOWING SIGNS OF FRACTURE MUST BE CHANGED AS SOON AS POSSIBLE". THE CEILING DISTRIBUTION ARM HAS BEEN REPAIRED AND IS RETURNED IN GOOD WORKING CONDITION. GETINGE USA, 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 * * BYX MAQUET S.A. * *

    Patients

    Seq Age Sex Outcome Treatment
    1