BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAULUX 3000

    MDR report key: 5323975 · Received December 23, 2015

    Report

    Report Number
    9710055-2015-01041
    Event Type
    Malfunction
    Date Received
    December 23, 2015
    Date of Event
    November 27, 2015
    Report Date
    November 30, 2015
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 12:18 PM (GMT-5:00) ADDED BY (B)(6) ((B)(4)): A MAQUET FIELD SERVICE TECHNICIAN VISITED THE HOSPITAL AND FOUND THAT THE CUPOLA CONNECTED TO THE SPRING ARM CAME OFF. THE BROKEN SPRING ARM WAS REPLACED WITH ANOTHER SPRING ARM. 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 A SURGICAL LIGHT SPRING ARM BROKE DURING A SURGERY IN THE OPERATING ROOM # 6 WHILE SURGEON TRIED TO MOVE THE CUPOLA. THE CUSTOMER INFORMED MAQUET THAT HE NOTICED GREAT RESISTANCE UNTIL IT BROKE. NO INJURIES WERE REPORTED, THE CUPOLA WAS NOT LOCATED ABOVE THE PATIENT. THE SURGERY HAD TO BE CONTINUED WITH THE SUBSTITUTION CUPOLA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849612 HANAULUX 3000 LAMP, SURGICAL FTD MAQUET SAS H5H3DF

    Patients

    Seq Age Sex Outcome Treatment
    1