BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAULUX 3000

    MDR report key: 5154150 · Received October 15, 2015

    Report

    Report Number
    9710055-2015-01017
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    September 15, 2015
    Report Date
    September 18, 2015
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Removal / Correction Number
    Z-0182/188-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCTOBER 14, 2015 09:41 AM (GMT-4:00) ADDED BY (B)(6): NOTE: THE HANAULUX 3000 SERIES LIGHT SYSTEM IS NOT MARKETED IN THE US. THIS REPORT HAS BEEN MADE DUE TO A SIMILARITY WITH DEVICES MARKETED BY MAQUET IN THE US. THIS MALFUNCTION WAS PREVIOUSLY ADDRESSED IN THE U.S. THROUGH THE DEVICE CORRECTION Z-0182/188-2010. A MAQUET FIELD SERVICE TECHNICIAN INSPECTED THE DEVICE AND FOUND THAT THE FRONT PIVOT OF THE SPRING ARM BROKE AT THE WELD SEAM. THE BROKEN SPRING ARM WAS REPLACED AND THE DEVICE RETURNED TO SERVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SPRING ARM BROKE DURING A SURGERY. THE LIGHTHEAD REMAINED SUSPENDED TO THE WIRES, AND NO INJURIES WERE REPORTED. THE NURSE INFORMED MAQUET THAT THE FISSURED WELD SEAM WAS DETECTED BY THE OR STAFF THE DAY BEFORE THIS EVENT. HOWEVER, THE OR STAFF DECIDED TO USE THE LIGHT BEFORE FIXING IT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682504 HANAULUX 3000 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS H5DUODF

    Patients

    Seq Age Sex Outcome Treatment
    1