BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1660718 · Received April 10, 2010

    Report

    Report Number
    1660718
    Event Type
    Malfunction
    Date Received
    April 10, 2010
    Date of Event
    March 12, 2010
    Report Date
    April 10, 2010
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CASE WAS IN SESSION. A LOUD BANG WAS HEARD. TEE SCREEN WAS BLANK. THE PROBE COULD NOT BE REMOVED FROM THE PATIENT AT THE TIME; IT WAS REMOVED AT THE END OF THE CASE WITHOUT HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ULTRASOUND IMAGING SYSTEM IYN PHILIPS ULTRASOUND, INC. HD11 XE *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR