BEUDAMED
    FDA Adverse Event Other Summary report: N

    9710055-2008-00022

    MDR report key: 1325769 · Received February 3, 2009

    Report

    Report Number
    9710055-2008-00022
    Event Type
    Other
    Date Received
    February 3, 2009
    Product Code
    FTD
    PMA / PMN Number
    K895715
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET SERVICE DOES NOT HAVE A MAINTAINENCE AGREEMENT WITH THIS CUSTOMER AND ALL SERVICE IS CONDUCTED BY THE HOSPITAL BIOMEDICAL TECHNICIANS. MANUFACTURER SERVICE REPRESENTATIVES VISITED THE CUSTOMER AFTER BEING INFORMED OF THE INCIDENT. THE SERVICE TEAM EXAMINED THE BROKEN RING AND FOUND IT TO BE WORN AND CRACKED. THE RING WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND FOUND TO EXHIBIT SYMPTOMS OF STRESS FRACTURES CONSISTENT WITH OVERTIGHTENING. PART INFO WAS PROVIDED TO THE CUSTOMER AT THE TIME OF THE INCIDENT AND THEY STATED THEY WOULD COMPLETE THE REQUIRED REPAIRS THEMSELVES. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FTD

    Patients

    Seq Age Sex Outcome Treatment
    1