BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACIST

    MDR report key: 612542 · Received June 7, 2005

    Report

    Report Number
    2134243-2005-00004
    Event Type
    Other
    Date Received
    June 7, 2005
    Date of Event
    April 19, 2004
    Report Date
    June 6, 2005
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 05/2005 THE USER FACILITY REPORTED THAT AIR WAS INJECTED INTO THE PT DURING AN ANGIOGRAPHIC PROCEDURE SEVENTEEN DAYS EARLIER. A PHYSICIAN AT THE USER FACILITY REPORTED THAT THERE WERE NO PT ADVERSE EFFECTS NOTED. THE USER FACILITY MADE NO ALLEGATIONS OF DEVICE MALFUNCTION.

    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