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

Consumer and regulatory updates

23 September 2021

The TGA has heard from many people affected by this action. We appreciate your feedback and recognise the seriousness of your concerns. Hearing from you assists us in our discussions with Philips to ensure the effectiveness of their proposed actions.

The estimated start date for remediation activities in Australia was September; Philips has now stated that an initial delivery of DreamStation devices will be sent in late September and replacement work for these devices will start in mid-October. Philips' parent company has announced that the repair/replacement program is expected to be completed within approximately 12 months.

This recall is being coordinated globally and relies heavily on manufacturing capacity and importation of materials from overseas. The TGA will monitor the timelines outlined by Philips in their remediation plan and continue to raise issues that need to be addressed by the company.

We are also working with manufacturers of alternative devices to encourage increased supplies to be made available in Australia, noting the competition with other global markets for such devices.

A recall action should not commence in Australia until the proposed action and communication are agreed to by the TGA. We give this agreement when we are satisfied that the action effectively mitigates the risks posed by an issue with a therapeutic good.

As part of our assessment, we often seek expert medical or scientific advice. Shortly after this recall action was announced, we convened our Ventilator Expert Working Group, comprising state and territory health officials, external independent clinicians, biomedical engineers and peak health professional bodies such as the Australasian Sleep Association. The Working Group provides feedback on the appropriateness of the actions and communications from both the TGA and Philips.

After a recall commences, we monitor its effectiveness to ensure all affected product is fixed or removed from the market where this is needed. In some instances, further investigations or enforcement actions may also occur.

In reviewing Philips' proposed actions, we have concluded that in many instances total removal (recall) of the affected devices is not possible unless sufficient replacements are available. We are aware there are limited supplies of alternative devices and understand the risks posed by interrupting patient treatment. Recognising that individual needs differ, it is important that each patient seeks advice from their own healthcare professional.

We recognise and understand this places significant pressure on health professionals. The course of action for each patient, i.e. immediate replacement, adjustment, interruption, or continued use until repair/exchange, must be assessed in each case. The decision should be based on the currently available information on risks and individual patient circumstances (type and severity of respiratory disorder, age, comorbidities, symptoms, occupation, duration of therapy, etc.)

A 'product defect correction' may be called a 'recall' in some international markets and identified in this way on the websites of other regulatory agencies. However, the advice for users to contact a health professional before making changes to treatment, and the approach of repair / replacement of the devices, remains consistent across the world. We are working closely with international regulators on this Philips recall action to support a consistent approach.

The TGA has commenced a post-market review of other products in the 'sleep device' category included in the Australian Register of Therapeutic Goods (ARTG). This review will confirm if other devices are also affected by degrading sound-insulating foam. Information on the outcomes of this review will be published on our website.

At present, use of an inline bacterial filter has been recommended for mechanical ventilators only. The filter will provide a barrier to prevent users from inhaling the degraded foam particles, but it will not protect against the gases that may be released by the foam. If the filter becomes wet or clogged with debris it may reduce device performance and should be replaced frequently as referenced in the device's user manual.

Use of an inline bacterial filter is not currently recommended for CPAP / Bi-Level PAP devices.


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

18 August 2021

The TGA continues to receive enquiries from consumers concerned about progress with this recall action. Please see the following information we have provided on common questions.

Where possible Philips Electronics Australia Pty Ltd has sent letters directly to patients. In some cases, patients are not directly managed by Philips because other companies have taken on the responsibility of supplying the devices to customers. These distributor companies will be responsible for sending the letters to their customers. Who sends you the letter will be based on the information you have provided Philips or the place where you purchased your device.

In addition to direct patient letters, Philips have used a variety of ways to let people know about the recall. These include publication of information on the Philips' website, advertising the recall in print and digital newspapers and notifying relevant healthcare associations and patient support organisations.

The TGA has also notified key stakeholders including state and territory health departments, the Australian Government Primary Health Networks, consumer groups and associations. We have also sent information using our social media channels.

Various television and media outlets have published articles about this recall and users are sharing information across social media support groups. We remind all patients and their caregivers to use the TGA website for accurate information.

Some consumers are concerned that the Philips website includes advice that -

"the repair process for existing devices requires regulatory approval in your country, which we are working toward obtaining as quickly as possible. We will begin the repair/replacement process immediately upon that approval."

This statement only applies in some countries. The repair / replacement process does not require regulatory approval in Australia.

Philips Australia is waiting for stock of replacement foam to arrive from overseas. This is expected to arrive in September for the DreamStation platform and the repair/replacement plan will start as soon as possible after this happens. The TGA will provide another update when corrective actions have commenced.

If customers have already purchased a replacement CPAP machine, please register your affected device at www.philips.com/src-update and click on "Begin registration process". Philips will provide instructions on how to return your affected device.

Philips is responding to consumer requests for refunds. If you are not satisfied with the refund or reimbursement offered, you should request the offer be reviewed. You can do this via the Philips Electronics Australia Ltd support hotline on 1800 009 579.

In addition, you have rights under the Australian Consumer Law which are entirely separate to any remedy Philips may provide as part of this recall action. You can find more information on the Australian Competition & Consumer Commission (ACCC) website about your consumer guarantee rights.

The TGA does not administer consumer law. You can make a consumer complaint to the ACCC if you experience difficulties asserting your rights regarding the Philips products covered by this recall action.


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

Update - further information for consumers

16 July 2021

If you have not already done so, please register your device at www.philips.com/src-update. This information is needed so the company can plan the repair/replacement program efficiently.

Some consumers have reported that they are not sure if their registration has been received. When you register you will get a registration number. If you don't receive this number, please re-register your device. To help reduce this confusion, Philips is now sending a confirmation email with each new registration.

Other consumers have purchased their device overseas and are not sure if they should register here. If you currently live in Australia, regardless of the place of purchase, go to the Philips registration website and select 'Australia' before entering your serial number.

Towards the end of this month, Philips will begin contacting everyone who has registered their device. They will confirm your details and outline the type of correction proposed for your device. This may take some time given the large number of affected people. Depending on the device type and its age, Philips will either provide a new base unit device or replace the foam component.

We will continue to update you as further information becomes available.


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

Update - Product defect correction

9 July 2021

The TGA is aware that some consumers are having difficulty contacting Philips about the safety concerns with their devices. The company has advised us that additional resources are being put in place to help with the high level of calls.

It is important that customers register their devices on the Philips website. This will help us plan an effective approach to either repair or replace them, taking into account the specific needs of various patient groups. Some additional guidance on registering is outlined below.

We will publish further information on repair and replacement timeframes as soon as this is available. The TGA is assessing safety information to ensure any proposed actions are appropriate - these may be different for different devices. Philips has confirmed that replacing the device or replacing the foam will be done at no cost to the patient.

It is strongly recommended that you do not attempt to remove the foam yourself and then continue using your device. Discuss your concerns with your health professional and register your device on the Philips website.

Information for consumers

You need to register your device on the Philips support website. Please follow these steps:

  1. Go to www.philips.com/src-update and click on "Begin registration process"

    (For further information, you can also scroll down to the "Patient, Users, or Caregivers" heading and then click on "Begin registration process")

  2. Select your user or customer category and choose "Australia" as the country (even if you purchased your device overseas)
  3. Continue to follow the remaining steps, ensuring you enter your device's Serial Number to check if your device is affected
  4. If your device is affected, you will be asked to register your device.

Experiencing problems

If you are experiencing any of the symptoms listed below, talk with your health professional. We also encourage consumers and health professionals to report problems with medical devices to the TGA.

We will publish further updates as new information becomes available, to continue providing support for all users, health professionals and customers impacted by this issue.

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.


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

Product defect correction - safety hazard caused by foam degradation and emissions

6 July 2021

Philips Electronics Australia Ltd, following consultation with the TGA, is undertaking a product defect correction for 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. 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.

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.

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.

CPAP and BiLevel PAP Devices

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

Mechanical Ventilators

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.