BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 533455 · Received June 4, 2004

    Report

    Report Number
    533455
    Event Type
    Other
    Date Received
    June 4, 2004
    Date of Event
    May 20, 2004
    Report Date
    June 2, 2004
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN SETTING UP THE ACIST THE MANIFOLD WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * AUTOMATED MANIFOLD KIT DTL ACIST MEDICAL SYSTEMS, INC. BT2000 0504A

    Patients

    Seq Age Sex Outcome Treatment
    1 *