BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST AUTOMATED MANIFOLD KIT

    MDR report key: 3015710 · Received March 18, 2013

    Report

    Report Number
    MW5029412
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ACIST MEDICAL SYSTEMS
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VALVE IN TUBING SYSTEM CAUSED AIR TO BE DRAWN INTO THE ACIST CONTRAST POWER INJECTION SYSTEM. THE ACIST DETECTED THE AIR AND STOPPED THE INJECTION. NO HARM TO ANY PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112424 ACIST AUTOMATED MANIFOLD KIT MANIFOLD KIT DXT ACIST MEDICAL SYSTEMS BT2000

    Patients

    Seq Age Sex Outcome Treatment
    1