List of ventilator, CPAP, and BiPAP devices containing PE-PUR foam material in the breathing gas pathway

We are reviewing all ventilator, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) devices in the Australian Register of Therapeutic Goods (ARTG) to determine whether the devices incorporate harmful sound abatement foam. 

This action follows the identification of risks posed by a polyester-based polyurethane (PE-PUR) foam used as soundproofing material in devices supplied by Philips Electronics Australia Ltd.

During the review we identified additional devices (other than those supplied by Philips Electronics Australia Ltd) that contain PE-PUR foam material for sound abatement purpose in the breathing gas pathway. 

We requested evidence regarding the long-term safety to ensure these devices are safe for use throughout their expected service life.

Although these additional devices contain PE-PUR foam material, there are different kinds of PE-PUR foam and it may not be the same material grade used in the devices supplied by Philips Electronics Australia Ltd. 

We have carefully reviewed each device to understand the composition of the foam used and whether it poses safety risks over time. Each device has been assessed individually to ensure it meets the relevant safety and performance requirements. 

Below is the list of other devices (i.e. not supplied by Philips Electronics Australia Ltd) that contain PE-PUR foam material for sound abatement purposes with final outcomes of any regulatory action the TGA may have taken. 

We have taken regulatory actions where non-compliances were identified. Currently there are no PE-PUR foam containing devices being supplied in Australia.

Published: Information about Philips' recall action of correcting their affected devices