Events

Recall of Oxylog 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-2014-RN-00168-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00168-1
  • 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
    The manufacturer has received reports of devices displaying the error message “poti unplugged”.The investigation has revealed that a limited batch of control panel pcbs - onto which the potentiometer for setting the ventilation parameters is soldered, is faulty. this can result in the contact to the respective potentiometer being interrupted. the device then discontinues ventilation, gives an audible alarm and displays the error message poti unplugged. if this error occurs the user must immediately commence ventilation using an independent ventilator (manual ventilation bag) as specified in the instructions for use manual.
  • Action
    Draeger are recommending users commence manual ventilation as specified in the Instructions for Use (IFU) if the error occurs. Draeger will be contacting all affected users to organise the correction of the affected devices.

Device

Oxylog Transport Ventilator
  • Model / Serial
    Oxylog Transport VentilatorModels: Oxylog 3000plus and Oxylog 2000plusSerial Numbers: ASEJ-0138, ASEK-0011ARTG Number: 169507
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd