BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYL

    MDR report key: 599124 · Received May 4, 2005

    Report

    Report Number
    9611125-2005-00001
    Event Type
    Malfunction
    Date Received
    May 4, 2005
    Date of Event
    April 6, 2005
    Report Date
    May 2, 2005
    Manufacturer
    ESAOTE S.P.A.
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS MEASUREMENTS FROM ONE REPROT APPEARING ON A DIFFERENT REPROT. MIXING REPROT DATA BETWEEN PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYL ULTRASOUND IMAGING SYSTEM IYN ESAOTE S.P.A. 9807300001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA