BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X10 DSFV OR LIGHT - SPECIFICALLY THE 9 PIN CONNECTOR

    MDR report key: 866157 · Received May 18, 2007

    Report

    Report Number
    866157
    Event Type
    Malfunction
    Date Received
    May 18, 2007
    Date of Event
    May 14, 2007
    Report Date
    May 18, 2007
    Manufacturer
    GETINGE USA, INC.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    THIS IS THE FOURTH TIME IN THE RECENT PAST IN WHICH THE 9-PIN CONNECTOR SHORTED OUT AND STARTED A FIRE DURING AN OR CASE. THE CONNECTOR IS LOCATED IN THE "SPRING ARM" AND CONNECTS WITH THE LIGHT HEAD AT AN ELBOW. TO DATE, MANUFACTURER HAS NOT PROVIDED ACCEPTABLE RESOLUTION TO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X10 DSFV OR LIGHT - SPECIFICALLY THE 9 PIN CONNECTOR LIGHT, SURGICAL FSY GETINGE USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *