Events

Recall of eVent Medical Inspiration LS & i Series Ventilator Systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia.

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-2015-RN-01059-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-10-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01059-1
  • 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
    Investigations have identified that a component on the systems power board can fail in a manner which can cause the ventilator to shut down without the alarm being triggered. this failure could result in death or serious injury to a patient.
  • Action
    Users should discontinue use of the affected ventilators immediately until correction is completed. The manufacturer, eVent Medical has identified a correction to this issue which requires removal of the potentially faulty component from the power board. The corrective action will be undertaken by Taleb Medical during the month of November 2015. This action has been closed-out on 17/08/2016.

Device

eVent Medical Inspiration LS & i Series Ventilator Systems

Manufacturer

The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia