BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 370665 · Received January 7, 2002

    Report

    Report Number
    MW1023778
    Event Type
    Malfunction
    Date Received
    January 7, 2002
    Date of Event
    December 20, 2001
    Report Date
    December 28, 2001
    Manufacturer
    ACIST MEDICAL SYSTEMS
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ACIST TOUCH SCREEN WENT BLACK AND LOST POWER AFTER FIRST INITIAL INJECTIONS TO CORONARY ARTERIES. UNABLE TO CONTINUE WITH ACIST DUE TO LOSS OF INFO AND POWER TO TOUCH SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTOR DXT ACIST MEDICAL SYSTEMS CL-100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other