BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTEN

    MDR report key: 6102625 · Received November 15, 2016

    Report

    Report Number
    9710055-2016-00096
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    September 29, 2016
    Report Date
    October 19, 2016
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN (FST) EVALUATED THE DEVICE AND FOUND THAT THE PAINT PEELING OFF FROM THE JUNCTION BETWEEN SPRING ARM OF THE LIGHT AND THE CUPOLA. PENDING REPAIR, THE CUSTOMER PROTECTED THE DEVICE WITH PLASTIC WRAP TO PREVENT ANY PAINT PARTICLE FELL OFF. MAQUET DETERMINED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATION DUE TO THE USE OF WRONG CLEANING PRODUCT. ADDITIONALLY THE DEVICE WAS DIRECTLY INVOLVED WITH THE REPORTED INCIDENT AND WAS BEING FOR TREATMENT OF PATIENT WHEN THE EVENT OCCURRED. PER THE LABELING, USERS SHOULD "CHECK THE LIGHTHEADS FOR CHIPPED PAINT, IMPACT MARKS AND ANY OTHER DAMAGE" ON DAILY BASIS. MAQUET RECOMMENDS TO USE CLEANING PRODUCT WITHOUT "GLUTARALDEHYDE, PHENOL, IODINE, BLEACH, ETHYL ALCOHOL" (XTEN LABELLING 0130122201 EDITION 1).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, DURING A SURGERY, SOME PAINT PARTICLES FELL OFF ONTO THE SURGICAL FIELD. THERE WERE NO INJURIES REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755709 XTEN LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS X10/DF

    Patients

    Seq Age Sex Outcome Treatment
    1