BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILAB ULTRASOUND

    MDR report key: 1932674 · Received December 14, 2010

    Report

    Report Number
    MW5018608
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING A CARDIAC ABLATION. THE PHYSICIAN WAS UTILIZING A NEEDLE PUNCTURE DEVICE TO GAIN ACCESS TO THE LEFT ATRIUM. THIS ACCESS IS GUIDED BY ULTRASOUND (ILAB) AND FLUOROSCOPY. DURING THE PROCEDURE, THE ILAB ULTRASOUND IMAGE FROZE, RENDERING THE EQUIPMENT AND IMAGE USELESS. AN OLDER ULTRASOUND MACHINE USED FOR BACKUP WAS UTILIZED TO COMPLETE THE PROCEDURE. THE PT WAS NOT INJURED. IN THE PAST SEVERAL MONTHS, THREE MAJOR COMPONENTS OF THIS EQUIPMENT HAVE BEEN CHANGED OUT DUE TO MALFUNCTION. THESE COMPONENTS INCLUDE THE ACQUISITION COMPUTER, THE MOTOR DRIVE, AND THE MOTOR DRIVE INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILAB ULTRASOUND ULTRASOUND MACHINE IYO BOSTON SCIENTIFIC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention