BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTEN

    MDR report key: 5489881 · Received March 9, 2016

    Report

    Report Number
    9710055-2016-00017
    Event Type
    Malfunction
    Date Received
    March 9, 2016
    Date of Event
    February 15, 2016
    Report Date
    February 16, 2016
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 03/09/2016 05:08 PM (GMT+1:00) ADDED BY (B)(6): THE THIRD PARTY COMPANY TECHNICIAN EVALUATED THE DEVICE AND FOUND A BROKEN WELD SEAM AT THE CONNECTION BETWEEN THE SPRING ARM AND THE LIGHTHEAD. THE TECHNICIAN REMOVED THE BROKEN SPRING ARM FROM SERVICE, PENDING REPAIR. MAQUET SUPPLIED A REPLACEMENT SPRING ARM TO THE THIRD PARTY COMPANY, SO THEY CAN PERFORM THE REPAIR.

    Description of Event or Problem · 1

    ON 03/09/2016 11:32 AM (GMT-5:00) ADDED BY (B)(6): A THIRD PARTY COMPANY REPORTED THAT THE SPRING ARM'S SURGICAL LIGHT WAS BROKEN ON THE WELD AND HIT THE PATIENT DURING SURGERY IN THE OR #9. NO INJURIES TO PATIENT NOR STAFF WERE REPORTED. (B)(4). ON 03/09/2016 04:43 PM (GMT+1:00) ADDED BY (B)(6): A THIRD PARTY COMPANY REPORTED THAT THE SPRING ARM'S SURGICAL LIGHT WAS BROKEN ON THE WELD AND HURT THE PATIENT DURING A SURGERY IN THE OR #9. NO INJURIES TO PATIENT NOR STAFF WERE REPORTED. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146836 XTEN LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS XTENDUODFV

    Patients

    Seq Age Sex Outcome Treatment
    1