Events

Recall of Hamilton Medical C3 Ventilator

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-2016-RN-01134-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01134-1
  • 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 identified an issue related to spo2 monitoring with the use of the hamilton-c3 ventilator. when measuring spo2, the software of the hamilton-c3 can run into a system or cpu overload causing a screen freeze. the alarm buzzer sounds and the device needs to be reset. in case of such a system or cpu overload, the hamilton-c3 stops the ventilation and sounds the alarm buzzer. however, since the screen freezes, no alarm message is displayed to the operator. there have been no injuries reported as a result of this issue.
  • Action
    All the Hamilton-C3 ventilators have SpO2 option deactivated by default as there are no SpO2 sensors in use in Australia. The new software version 2.0.2 will be installed as a permanent correction. This action has been closed-out on 15/02/2017.

Device

Hamilton Medical C3 Ventilator

Manufacturer

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