TGA Therapeutic Goods Administration : Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

Philips Electronics Australia Ltd, following consultation with the TGA, is undertaking a product defect correctionfor the 14 sleep and respiratory care devices identified in the tables below. This is in response to risks posed by the polyester-based polyurethane (PE-PUR) sound abatement foam component in these goods.

Philips has identified that the foam used in the blower boxes of their continuous and non-continuous ventilators may degrade into particles, which may enter the devices' air pathway and be ingested or inhaled by the user, and release certain chemicals as gases. The foam may degrade more quickly if the device is cleaned using unapproved cleaning methods, such as ozone gas products.

Where possible, Philips will replace the sound abatement foam in affected devices. If this is not possible, a replacement device will be provided.

Information for consumers

Check the list of devices lower on this page to see if your device is affected by this action.

Do not stop using your device without speaking to your physician or care provider. Stopping treatment suddenly could have an immediate and detrimental effect on your health.

You need to register your device on the Philips support website: www.philips.com/src-update(link is external). This will allow Philips to contact you to organise the corrective actions or a replacement device.

If you have any questions or concerns, contact Philips Electronics Australia Ltd on 1800 009 579. Further information is available at www.philips.com/src-update(link is external).

If your device is an affected CPAP or bi-Level PAP unit

Please make an appointment with your physician or care provider before making any changes to your prescribed therapy. Together with your physician, determine if the benefit of continuing therapy with your device outweighs the risks identified and discuss alternative long-term therapy options.

Please ensure you follow the recommended cleaning and replacement guidelines in the operating manual for your CPAP machine and accessories.

If your device is an affected mechanical ventilator

Do not stop or alter your prescribed ventilator therapy.

Please make an appointment with your physician or care provider before making any changes to your prescribed therapy. Together with your physician, determine if the benefit of continuing therapy with your device outweighs the risks identified and discuss alternative long-term therapy options.

You can use an inline bacterial filter to help reduce the risk of inhaling particles of foam. These filters will not reduce exposure to the gases that may be released by the degrading foam.

Guidance on installation of the filter is found in the device's operating manual. It is important to install these correctly as a filter may increase the resistance of air flow.

Information for health professionals

Please be aware of the safety concerns associated with these devices and advise patients accordingly. A patient-specific risk assessment may be needed to determine whether the benefits of continuing therapy outweighs the risks identified.

If you have any questions or concerns about this issue, please contact Philips Electronics Australia Ltd support hotline on 1800 009 579. Further information is available at www.philips.com/src-update(link is external).

Risk assessment outcomes

Philips' investigations identified that the majority of particles are of a size unable to penetrate into deep lung tissue and are likely to remain in the patient's upper airway. Only particles with a diameter of <1-3 μm may penetrate into the lower respiratory tract.

Analysis of the degraded foam demonstrates the particles may include compounds such as diethylene glycol (DEG), toluene diamine isomers (TDA) and toluene diisocyanate isomers (TDI). Philips is undertaking investigations to assess whether the amount of degraded PE-PUR foam inhaled and/or ingested by a patient may potentially exceed the tolerable intake for these compounds.

The foam may also emit certain chemicals (volatile organic compounds - VOCs). Product testing has shown that this 'off-gassing' mostly occurs during initial operation, but may possibly continue throughout the device's useful life. These VOCs include dimethyl diazene and phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl).There is no known permissible daily exposure limit for these compounds.

The potential risks associated with these issues include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), inflammatory responses, asthma, hypersensitivity, nausea / vomiting, adverse effects to other organs (e.g. kidneys and liver) and possible carcinogenic effects.

The complaint rate associated with these issues was 0.03% for the year 2020. To date, there is no definitive evidence of long-term harm to patients and there have been no reports of death.

Update - Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

Safety hazard caused by foam degradation and emissions

25 June 2021

The TGA is now able to confirm that the following devices are affected by this action.

All devices manufactured before 26 April 2021 All serial numbers
Continuous Ventilator, Minimum Ventilatory Support, Facility Use	E30 (Emergency Use Authorization)
Continuous Ventilator, Non-life supporting	DreamStation ASV
	DreamStation ST, AVAPS
	SystemOne ASV4
	C-Series ASV
	C-Series S/T and AVAPS
	OmniLab Advanced+
Noncontinuous Ventilator	SystemOne (Q-Series)
	DreamStation
	DreamStation Go
	Dorma 400
	Dorma 500
	REMstar SE Auto

All devices manufactured before 26 April 2021 All serial numbers
Continuous Ventilator	Trilogy 100
	Trilogy 200
Continuous Ventilator, Minimum Ventilatory Support, Facility Use	A-Series BiPAP V30 Auto
Continuous Ventilator, Non-life supporting	A-Series BiPAP A40
	A-Series BiPAP A30

If your device is an affected mechanical ventilator, use of an inline filter will reduce the risk of inhaling particles of foam. Guidance on installation of the filter is found in the device's Instructions for Use document (or 'operating manual').

We re-iterate our earlier advice that, in critical or lifesaving situations, patients or caregivers should continue using the devices until an alternative becomes available. Patients should speak with their health professional prior to making any changes to their prescribed therapy.

Where possible, affected devices will have the sound abatement foam component replaced. Information on the timing of this correction is still being confirmed with Philips.

We will publish further information as soon as it becomes available, including advice that the recall action has commenced in Australia and the outcomes of TGA's risk assessment.

Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

Safety hazard caused by foam degradation and emissions

18 June 2021

The TGA is working with Philips on its global recall action for Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (Bi-Level PAP) devices and mechanical ventilators due to risks posed by the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.

The majority of the affected devices are in the first-generation DreamStation product family.

A full risk assessment is underway including numbers supplied in Australia and on potential particulate and chemical exposure risks which will inform further advice to health professionals and consumers.

As a precautionary measure, pharmacies are advised to quarantine and remove from sale any unsold units of the affected devices.

We will continue to work with Phillips to ensure that comprehensive information is made available as quickly as possible through formal published announcements on the TGA website and from Phillips directly to customers.

Information for consumers

For devices currently in use in critical or lifesaving situations, patients or caregivers should continue using the devices until an alternative becomes available.

Information for health professionals

Please be aware of the above issue and advise patients accordingly if they seek advice.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.