BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 975732 · Received July 20, 2007

    Report

    Report Number
    9710055-2007-00019
    Event Type
    Other
    Date Received
    July 20, 2007
    Date of Event
    May 14, 2007
    Report Date
    May 16, 2007
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT PROBLEM IS LIMITED TO X'TEN SURGICAL LIGHT SYSTEMS WITH SINGLE FORK, VIDEO FEATURE. REVIEW AND IMPROVEMENTS TO PROCESSES AT THE SUPPLIER OF THE SPRING ARM WERE IMPLEMENTED. SPRING ARM WAS REMOVED FROM USE AND REPLACED WITH A NEW ARM. CUSTOMER REFUSED TO TURN OVER CONNECTOR FOR EVAL BY THE MFR. GETINGE USA, INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET S.A. PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    LOW VOLTAGE CONNECTOR IN LIGHT ARM MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM FSY FSY MAQUET S.A. X'TEN *

    Patients

    Seq Age Sex Outcome Treatment
    1