BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVID E9 WITH 6TC PROBE

    MDR report key: 2558122 · Received April 26, 2012

    Report

    Report Number
    9610482-2012-00005
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Date of Event
    March 29, 2012
    Report Date
    March 29, 2012
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K081921
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRANSESOPHAGEAL (TEE) PROBE CONTROL HANDLE ALLOWS PROPER FORWARD DEFLECTION TO THE 120 DEGREE LIMIT BUT THEN CAN EASILY BE BENT PAST THIS LIMIT MANUALLY. WITH THE PROBE IN THE PT IT WAS MANUALLY DEFLECTED PAST THE LIMIT MAKING IT DIFFICULT TO WITHDRAW. NO INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIVID E9 WITH 6TC PROBE ULTRASONIC IMAGING SYSTEM IYN GE VINGMED ULTRASOUND AS KN100105

    Patients

    Seq Age Sex Outcome Treatment
    1