BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAULUX3000

    MDR report key: 6078551 · Received November 4, 2016

    Report

    Report Number
    9710055-2016-00095
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 14, 2016
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Removal / Correction Number
    Z-0182/188-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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. A MAQUET FIELD SERVICE TECHNICIAN (FST) EVALUATED THE DEVICE AND FOUND A BROKEN WELD SEAM AT THE JOINT FRONT PIVOT. THE FST REPLACED THE SPRING ARM WITH A NEW ONE AND RETURNED THE DEVICE TO SERVICE. ADDITIONALLY, THE DEVICE WAS DIRECTLY INVOLVED WITH THE REPORTED INCIDENT AND WAS USED FOR TREATMENT OR DIAGNOSIS OF THE PATIENT WHEN THE EVENT OCCURRED. 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 AFTER A SURGERY, WHILE THE PATIENT WAS STILL ON THE OPERATING TABLE, THE LIGHTHEAD BROKE AWAY FROM THE SPRING ARM WHEN IT WAS MOVED BY OR STAFF. THE CUPOLA WAS RETAINED FROM FALLING BY THE CABLE. THERE IS NO INJURIES TO PATIENT NOR STAFF REPORTED. FACTORY REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730949 HANAULUX3000 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS H4H3DFV

    Patients

    Seq Age Sex Outcome Treatment
    1