Events

Recall of Dräger Carina Ventilator

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Draeger 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-2018-RN-00394-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-05-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00394-1
  • 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
    Draeger has been made aware that one component in the valve assembly of the carina ventilator was not sufficiently cleaned by a supplier. over time, this can result in the material of the valve assembly becoming corroded and can result in contamination of the breathing gas.This issue was identified during production at dräger. to date, no reports of adverse events have been received as a result of this issue.
  • Action
    Draeger is advising customers to remove the potentially affected devices from use immediately to exclude any further risk to patients. Draeger will provide affected sites with loan devices to alleviate any delays and/or downtime. Draeger will contact users (via Engineering Department) to schedule the replacement of the affected components.

Device

Dräger Carina Ventilator
  • Model / Serial
    Dräger Carina VentilatorSerial Numbers: ASKM-0074; ASKM-0075; ASKM-0076; ASKM-0077; ASKM-0078; ASKM-0079; ASKM-0080; ASKM-0082; ASKM-0083; ASKM-0084; ASKM-0085; ASKM-0086; ASKM-0087; and ASKM-0088ARTG Number: 140966(Draeger Australia - Ventilator, adult)
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd