Events

Recall of Drager Ventstar Paediatric Circuit, used in conjunction with the Dräger Oxylog 3000plus Transport Ventilator

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Draeger Medical Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00721-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-05-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00721-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    During the course of routine internal testing drager detected isolated leakages at the check valve (one way valve of the inspiration branch) of the above mentioned disposable paediatric ventilation circuit. leakage at the check valve can result in a patient's exhaled gas entering into the breathing circuit, which could lead to the rebreathing of the exhaled gas with subsequent reduced oxygen concentration for the patient. this leakage is not detected during the ventilator operational readiness check. to date, drager has not received any complaints associated with this issue.Further detailed investigations have shown that the check valve functions properly with no leak observed at positive end-expiratory pressures above 5 mbar i cmh20. the problem only occurs at peep values below 5 mbar i cmh20.
  • Action
    Drager urgently recommends that users immediately inspect any stock and dispose of any product (part number 5704964) with a date of manufacture up to and including 03-2016. A Free of charge replacement product can be obtained by following the instructions in the customer letter.

Device

Drager Ventstar Paediatric Circuit, used in conjunction with the Dräger Oxylog 3000plus Transport...

Manufacturer

Draeger Medical Australia Pty Ltd