BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAULUX 3000

    MDR report key: 5302520 · Received December 16, 2015

    Report

    Report Number
    9710055-2015-01038
    Event Type
    Malfunction
    Date Received
    December 16, 2015
    Date of Event
    November 17, 2015
    Report Date
    November 17, 2015
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 10:25 AM (GMT-5:00) ADDED BY (B)(6): A MAQUET FIELD SERVICE TECHNICIAN VISITED THE HOSPITAL AND FOUND THAT THE SPRING ARM WAS BROKEN. A NEW SPRING ARM HAS BEEN ORDERED TO REPLACE THE BROKEN PART. MAQUET IS NOT IN CHARGE OF MAINTENANCE OF THIS DEVICE. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SURGICAL LIGHT FELL DOWN JUST BEFORE THE BEGINNING OF SURGERY. A PATIENT WAS PRESENT IN THE OR BUT NO INJURIES WERE REPORTED. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832362 HANAULUX 3000 LAMP, SURGICAL FTD MAQUET SAS H4H3DFV

    Patients

    Seq Age Sex Outcome Treatment
    1