BEUDAMED
    FDA Adverse Event Other Summary report: N

    HNAULUX

    MDR report key: 2971399 · Received April 20, 2007

    Report

    Report Number
    9710055-2007-00009
    Event Type
    Other
    Date Received
    April 20, 2007
    Date of Event
    March 2, 2007
    Report Date
    March 22, 2007
    Manufacturer
    MAQUET SA
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CHIPPING WAS OBSERVED ON DIFFERENT PARTS OF THE SURGICAL LIGHT (YOKE, BULB COVER CAPS, CENTRAL AXLE). THE ROOT CAUSE OF THIS EVENT IS THE USE OF A CLEANING PRODUCT WHICH IS NOT RECOMMENDED INTO THE USER'S MANUAL. THIS DEGRADED CONDITION IS DETECTABLE BY INSPECTION BEFORE USE OF THE SURGICAL LIGHT AND DURING THE ANNUAL PREVENTIVE MAINTENANCE PROGRAM. IN THIS HOSPITAL, THE MAINTENANCE OF SURGICAL LIGHTS IS PERFORMED BY A THIRD PARTY. AN ESTIMATE FOR REPAIRS IS BEING PROVIDED. (B)(4) SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE, INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE (CESAREAN), WHEN POSITIONING THE SURGICAL LIGHT, A PAINT CHIP FELL DOWN FROM THE LIGHT HEAD AND LANDED CLOSE TO THE PT'S LEGS. NO CLINICAL CONSEQUENCES HAVE BEEN REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HNAULUX FSY MAQUET SA HLX 2005

    Patients

    Seq Age Sex Outcome Treatment
    1