Events

Safety Alert for HAMILTON-T1 Ventilator

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Hamilton Medical AG.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-01-04
  • Event Date Posted
    2013-01-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130104a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: hamilton medical ag hamilton-t1 ventilator it has come to our attention that medical device manufacturer, hamilton medical ag, has initiated a field safety corrective action concerning hamilton-t1 ventilator with software version <= 1.1.2. according to the manufacturer, there is unexpected high internal oxygen consumption of hamil ton-t1 ventilators during ventilation of small pediatric patients. the current labeling does not include sufficient information about the internal oxygen consumption of the ventilators. depending on the ventilator setting and the patient's lung impedance, the internal gas consumption of the hamilton-t1 may be higher than expected. the internal oxygen consumption has to be taken into account in addition to the oxygen requirements for the patient's ventilation, especially when oxygen is limited. if the available oxygen supply during transport is depleted, the life of the patient may be endangered. furthermore, the manufacturer will rework and provide updated hamilton-t1 labeling (e.G., operator's manual), and develop and provide updated software with optimized internal oxygen consumption and overall oxygen consumption monitoring. it also advises users to calculate the required oxygen capacity prior to transports. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 04 january 2013.

Device

HAMILTON-T1 Ventilator

Manufacturer

Hamilton Medical AG