BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACIST

    MDR report key: 566486 · Received January 14, 2005

    Report

    Report Number
    2134243-2005-00001
    Event Type
    Other
    Date Received
    January 14, 2005
    Date of Event
    December 12, 2004
    Report Date
    January 13, 2005
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    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 THE PT EXPERIENCED TRANSIENT MILD CHEST PAIN AND ECG CHANGE BUT NO OTHER SYMPTOMS. ADDITIONAL INFO WAS REQUESTED FROM THE USER FACILITY BY THE DIST BUT AS OF THE DATE OF THIS REPORT THERE WAS NONE MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTOR SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CL100H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other