BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 4735642 · Received February 13, 2015

    Report

    Report Number
    4735642
    Event Type
    Malfunction
    Date Received
    February 13, 2015
    Date of Event
    February 11, 2015
    Report Date
    February 13, 2015
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ACIST MEDICAL INJECTOR INJECTED AIR BUBBLES INTO THE SYSTEM. THERE ARE SCANNERS THAT ARE SUPPOSED TO PREVENT THIS AND ALERT STAFF AND SHUT THE MACHINE DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107785 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR JUST NORMAL DEVICES NEEDED DURING HEART CATHS