BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 977319 · Received March 16, 2007

    Report

    Report Number
    9710055-2007-00007
    Event Type
    Other
    Date Received
    March 16, 2007
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SURGICAL LIGHT BELONGS TO AN OLD GENERATION OF LIGHTHEAD WHICH WAS MANUFACTURING PRIOR TO OWNERSHIP OF HANAULUX PRODS BY MAQUET S.A. THE ROOT CAUSE OF THE PEELING PAINT AND ITS LACK OF ADHESION COULD BE RELATED TO THE SURFACE PREPARATION WITHIN THE PAINTING PROCESS USED BY THE PREVIOUS MFR. IN 2004, AS A NEW MFR, MAQUET S.A. IMPROVED THE PAINTING PROCESS OF SURGICAL LIGHTS HANAULUX 2000. FURTHERMORE, THE SURGICAL LIGHT PAINT CAN PEEL OFF IF THE CUSTOMER USES AGGRESSIVE CLEANING PRODUCTS WHICH ARE NOT RECOMMENDED IN THE USER'S MANUAL. THE COVER IS TO BE REPLACED ON THE SURGICAL LIGHT. 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 * * FSY MAQUET S.A. * *

    Patients

    Seq Age Sex Outcome Treatment
    1