BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 1081731 · Received July 25, 2008

    Report

    Report Number
    2134243-2008-00005
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 23, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACIST CONTRAST INJECTION SYSTEM WAS TAKEN OUT OF SVC IN 2008 AND WAS RETURNED TO ACIST FOR TESTING. THE SYSTEM WAS TESTED AND MET ALL PRE-ESTABLISHED SPECS. THE DISPOSABLE KITS USED DURING THE PROCEDURE WERE DISCARDED BY THE HOSP; THEREFORE, NO ANALYSIS CAN BE MADE ON THESE ITEMS. NO DEFINITE CONCLUSION CAN BE MADE AS TO THE CAUSE OF THIS EVENT. THIS REPORT IS CLOSED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS: DURING AN INTERVENTIONAL CARDIAC ANGIOGRAPHY, WHILE USING THE ACIST E2000 VOYAGER CONTRAST INJECTION SYSTEM, A SMALL AMOUNT OF AIR WAS INJECTED INTO A PT. THE PT'S ECG SHOWED ST SEGMENT ELEVATION WITH A DURATION OF 1 - 2 MINUTES. NO OTHER ADVERSE HEALTH EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. E2000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L