BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 3951971 · Received June 20, 2014

    Report

    Report Number
    3951971
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, A SMALL AIR EMBOLUS WAS NOTED ON FLOUROSCOPY. AIR COLUMN SENSOR ON MACHINE DID NOT SENSE AIR. THERE WAS NO STOPCOCK MOVEMENT OR CATHETER ATTACHING PRIOR TO THIS AIR EMBOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363397 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR