BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT

    MDR report key: 1963000 · Received January 10, 2011

    Report

    Report Number
    1963000
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 10, 2011
    Manufacturer
    KIMBERLY-CLARK
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THIS IS A CLOSED SUCTION SYSTEM. THE BUTTON IS SUPPOSED TO POP UP AND THEN THE USER LOCKS THIS POSITION. THE BUTTON DID NOT POP UP. THE SUCTION DID NOT SHUT OFF. INITIALLY THOUGHT TO BE A VENTILATOR PROBLEM BUT WAS NOT RELATED TO THE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMVENT CLOSED SUCTION SYSTEM BSY KIMBERLY-CLARK 2205 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES