BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACIST

    MDR report key: 560628 · Received December 13, 2004

    Report

    Report Number
    2134243-2004-00013
    Event Type
    Other
    Date Received
    December 13, 2004
    Date of Event
    November 4, 2004
    Report Date
    December 10, 2004
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AIR WAS INJECTED INTO THE PT DURING AN ANGIOGRAPHIC PROCEDURE. A HEALTH CARE PROFESSIONAL AT THE USER FACILITY REPORTED THAT THERE WERE NO COMPLICATIONS WITH THE PT, AND THAT OTHER PHYSICIANS SUSPECT THAT THE EVENT OCCURRED DUE TO OPERATOR ERROR. ADDITIONAL INFO WAS REQUESTED FROM THE USER FACILITY BY THE DISTRIBUTOR BUT AS OF THE DAE OF THIS REPORT THERE WAS NONE MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CMS2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other