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:
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