BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 188023 · Received September 18, 1998

    Report

    Report Number
    MW1014608
    Event Type
    Malfunction
    Date Received
    September 18, 1998
    Date of Event
    August 18, 1998
    Report Date
    September 18, 1998
    Manufacturer
    DLP, DIV MEDTRONIC, INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CANNULA ALLOWED AIR TO ENTER HEART - LUNG BYPASS SYSTEM DUE TO A WEAK CONNECTION. AIR WAS REMOVED. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC CARDIO PLEGIA CANNULA 12G DWF DLP, DIV MEDTRONIC, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR