BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVID E9

    MDR report key: 3874021 · Received May 14, 2014

    Report

    Report Number
    3874021
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 14, 2014
    Manufacturer
    GENERAL ELECTRIC CO.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PRIOR TO A CARDIOVERSION. TEE WOULD NOT PROPERLY POWER UP. IMAGES WERE LOST. PATIENT DID HAVE CARDIOVERSION. TEE WAS NORMAL. SERVICE REPRESENTATIVE EVALUATED THE UNIT. THE SOFTWARE FROZE DURING USE, AND WAS UNABLE TO REBOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288172 VIVID E9 SYSTEM, IMAGING ITX GENERAL ELECTRIC CO. VIVID E9 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR