Important Safety Alerts

The Therapeutic Goods Administration (TGA) of Australia has issued an updated safety alert concerning Puritan Bennett 980 Universal Ventilator System, manufactured by Medtronic.

The original TGA's decision to suspend the PB980 ventilator from the Australian Register of Therapeutic Goods (ARTG), dated 18 September 2017, has been revoked following a review of the decision. However, the review has led to a new decision to suspend the PB980 ventilator from the ARTG. The suspension is for a period of six months commencing on 5 February 2018.

The TGA remains concerned that the use of these ventilators has a potential risk of death, serious injury or serious illness. Issues that formed the basis for this new suspension were as follows:

• The current presentation and labelling of the scalar waveform functions of the PB980 ventilator can convey markedly inaccurate values for flow and tidal volume. These values may be different to the ones displayed in the patient data banner;
• The potential sequelae of relying on those inaccurate flow and tidal volume values as opposed to the values displayed in the patient data banner; and
• The Graphic User Interface (GUI) is unreliable, because of instances of the screen going blank and the GUI becoming unresponsive.

According to the local supplier, the affected products are distributed in Hong Kong.

For details, please refer to the TGA website:
http://www.tga.gov.au/alert/puritan-bennet-980-series-ventilator

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 8 March 2018