BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVID I WITH 6T-RS TRANSDUCER

    MDR report key: 2063954 · Received March 23, 2011

    Report

    Report Number
    9610482-2011-00002
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 23, 2011
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K082374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BURNING SENSATION ON THE LIPS, TONGUE, AND THROAT FOLLOWING A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROCEDURE. TWO WEEKS FOLLOWING THE EXAM THE PATIENT STILL REPORTED A SWOLLEN TONGUE AND WAS REFERRED TO A SPECIALIST FOR INDEPENDENT ADVICE. PRELIMINARY EVALUATION INDICATES THAT THE TRANSDUCER PROBE MAY NOT HAVE BEEN CLEANED, DISINFECTED, OR RINSED PROPERLY RESULTING IN RESIDUAL CHEMICAL ON THE PROBE. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIVID I WITH 6T-RS TRANSDUCER ULTRASONIC IMAGING SYSTEM IYN GE VINGMED ULTRASOUND AS KN100093

    Patients

    Seq Age Sex Outcome Treatment
    1