BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN GANZ

    MDR report key: 7595807 · Received June 13, 2018

    Report

    Report Number
    7595807
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    February 27, 2018
    Report Date
    May 23, 2018
    Manufacturer
    EDWARD LIFESCIENCES LLC
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING RIGHT HEART CATH, THE DOCTOR NOTICED THAT THE PRESSURE READING FROM DISTAL PORT DID NOT CORRELATE WITH SWAN POSITION BASED ON FLUORO. CATHETER WAS REMOVED AND INSPECTED AND DISTAL PORT WAS CONNECTED TO PROXIMAL LUMEN. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437729 SWAN GANZ THERMODILUTION SWAN GANZ CATHETER DYG EDWARD LIFESCIENCES LLC 131F7 61176373

    Patients

    Seq Age Sex Outcome Treatment
    1