EnableNSW

TGA Product Defect Correction on some respiratory devices

Published: 14 Jul 2021

The Therapeutic Goods Administration (TGA) recently issued two (2) urgent product defect corrections on a range of Philips respiratory devices, including some CPAP machines, nocturnal Bi-level ventilators (BiPAP machines) and a continuous life-support ventilator. This list of affected devices is available on the Philips website.

The advice from Philips, the (TGA) and the Clinical Excellence Commission (CEC) is you should not stop using your device unless your respiratory clinician or care provider has told you to do so. Your clinician will work with you to decide if the benefit of continuing use of your current device outweighs the risks identified and discuss alternative long term options where available. If you are concerned, you should make an appointment with your respiratory clinician as soon as you can.

Our team is in the process of writing to all people who are using an affected Philips respiratory device. In this letter we let you know our team have registered your device with Philips and that Philips will make contact with you to discuss the correction (of the defect) or replacement of your device. If you know this situation impacts you and you have not received your letter from us by 20 July 2021, please contact our team on 1800 362 253 (option 3).

Due to this situation our team is experiencing a high volume of calls and you may wait longer than usual for your call to be answered. If you prefer, send an email to enable@health.nsw.gov.au and we will try and respond to you as quickly as we can.

We have some information on our website that may be helpful to you at this time.

We encourage you to contact the Philips team on 1800 009 579 with any questions or visit the Philips website regularly for more information.

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