BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET

    MDR report key: 1352855 · Received March 20, 2009

    Report

    Report Number
    9710055-2009-00003
    Event Type
    Other
    Date Received
    March 20, 2009
    Date of Event
    February 18, 2009
    Report Date
    February 18, 2009
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE TECHNICIAN WHO MADE THE TECHNICAL EVALUATION IN THE FIELD, DISCOVERED THAT THE FILTER BOARD OF THE POWER SUPPLY FAILED. THE FILTER BOARD WAS REPLACED AND THE LIGHTS ARE NOW FULLY FUNCTIONAL. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    MAQUET HAS BEEN NOTIFIED THAT TWO CUPOLAS X'TEN FROM THE SAME CONFIGURATION SWITCHED OFF AT THE SAME TIME DURING A SURGICAL PROCEDURE. THE CUSTOMER DID NOT REPORT ANY PROBLEMS COMPLETING THE PROCEDURE, NOR DID THEY INDICATE THAT A PT WAS ADVERSELY AFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1