Events

Recall of Hamilton Medical MR1 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-01133-1
  • 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-01133-1
  • 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
    An issue has been identified where the oxygen tubing and the oxygen connector of the hamilton-mr1 became loose during the preparation for ventilation. in the case of loose oxygen tubing during operation, the ventilation is continued and the “oxygen supply failed” alarm is triggered if the oxygen setting is above 21%. the oxygen connector may hurt the patient and the operator due to the high pressure of the oxygen and uncontrolled movement of the tubing. there have been no injuries as a result of this issue.
  • Action
    Taleb Medical is advising users to check the oxygen connector screws for tightness as an immediate measure. Tighten with a screwdriver if necessary. Do not over tighten the screws as this can damage the thread. If the oxygen connector cannot be tightened or if the screw-hole threads are damaged, do not use the ventilator. A new O2 mixer mounting plate will be installed as a permanent correction.

Device

Hamilton Medical MR1 Ventilator

Manufacturer

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