BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVID

    MDR report key: 10419631 · Received August 18, 2020

    Report

    Report Number
    10419631
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 7, 2020
    Report Date
    July 16, 2020
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING A PRE-ABLATION TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). TEE PERFORMED AND OK TO PROCEED WITH ABLATION. SHUT DOWN ECHO MACHINE IN ORDER TO GO BACK TO ECHO LAB. UPON STARTING MACHINE BACK UP AND TRANSMITTING IMAGES, THE MACHINE MALFUNCTIONED AND WOULDN'T SEND IMAGES. SERVICE TECHNICIAN CALLED IN. THE SOFTWARE WAS CORRUPT FOR UNKNOWN REASON. STUDY WAS NOT ABLE TO BE RECOVERED. IMAGES LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884938 VIVID SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN GE VINGMED ULTRASOUND AS E9 BT11 AND BT12 TO BT13 XDCLEAR UPG

    Patients

    Seq Age Sex Outcome Treatment
    1 19710 DA