Events

Safety Alert for Fabius Anaesthesia Machine

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Drägerwerk AG & Co KGaA.

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
    2018-03-01
  • Event Date Posted
    2018-03-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180301b.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: dräger fabius anaesthesia machine therapeutic goods administration (tga), australia, has issued a medical device safety alert concerning dräger fabius anaesthesia machine manufactured by drägerwerk ag & co kgaa .The affected products are identified as follows: device: fabius plus xl, fabius tiro, fabius gs premium and fabius plus xl. serial number: askm-0047, askh-0027, askh-0168, askh-0140 and askm-0246. the manufacturer has become aware of one case where the automatic ventilation failed during the operation of a fabius unit. this was due to the motor moving beyond the upper position and thereby damaging the ventilator cover. ventilation of the patient could reportedly be continued by means of the manspont mode and a manual resuscitator. according to the manufacturer, no serious injury has been reported to date. as a precaution the manufacturer will be updating relevant units. the manufacturer is advising they are currently producing replacement motors for the potentially affected devices. in the interim, the affected users may continue to operate the anaesthesia device with the usual attention and make sure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for use. for details, please refer to the following tga website: https://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2018-rn-00158-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 mar 2018.

Device

Fabius Anaesthesia Machine
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Dräger Fabius Anaesthesia Machine
  • Manufacturer
    Drägerwerk AG & Co KGaA

Manufacturer

Drägerwerk AG & Co KGaA