Events

Recall of Hamilton Galileo Ventilator when used with Flexport Communication Interface Protocol version 1.2

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtel 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-00582-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00582-1
  • 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 monitored minute volumes (vmin) are reported at ten times actual value on the bedside monitor. the source of this error is associated with a change in the flexport communication protocol between versions 1.1 and 1.2. all alarms and setting levels on the bedside monitor continue to perform properly and are unaffected by this error. the reported x10 volumes would be an obvious error to the clinician.
  • Action
    Medtel Australia is notifying their customers of the issue and advising that the ventilator performance is not affected. A software update will be implemented to correct the issue. This action has been closed-out on 12/02/2016.

Device

Hamilton Galileo Ventilator when used with Flexport Communication Interface Protocol version 1.2
  • Model / Serial
    Hamilton Galileo Ventilator when used with Flexport Communication Interface Protocol version 1.2Model Number: 90436A-07ARTG Number: 135706
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA