Philips Recall 2021 – Philips advises potential health risks for CPAP, BiPAP devices and mechanical ventilators.

By: Robert Afshari (B.Pharm.MPS)
Last Updated: 15/06/2021

CPAP-Online-Philips-DreamStation-Recall-2021

On 14th June 2021, Philips has announced a voluntary global recall of their CPAP and BiPAP devices, and mechanical ventilators. This is following the initial product update from 26th April 2021 where Philips said they were investigating a component in some of the respiratory care devices. This recall includes the most popular model by Philips, the DreamStation CPAP device range.

The recall notification informs customers and users of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken. In Australia and New Zealand, the local Philips entities (Philips ANZ) are currently engaging with the local regulatory bodies in relation to the recall action for Australia and New Zealand. Philips ANZ expects the recall action to commence in Australia and New Zealand soon.

The following information has been provided by Philips:

We are providing the following notices unchanged and as advised from the Philips Australia website as of 14/06/2021.

For patients using CPAP and BiPAP devices: 

  • Discontinue use of your Philips CPAP or BiPAP device immediately and work with your sleep consultant to find alternative sleep therapy.

For patients using life-sustaining mechanical ventilator devices:

  • Do not stop or alter your prescribed therapy until you have talked to your doctor or physician. Philips recognises that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks.
  • If your physician determines that you must continue using this device, use an inline bacterial filter. Consult your Instructions for Use for guidance on installation.

What is the issue and is there a safety hazard to keep using the affected devices?

Based on Philips analysis, the root cause of this issue is related to the sound abatement foam currently used in specific identified products of the Sleep & Respiratory Care portfolio.

The recall notification informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material.  High heat and high humidity environments may also contribute to foam degradation in certain regions.

Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which they operate.

In the event of exposure to degraded foam:

To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the air path circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.

  • The potential risks of degraded foam exposure include:
    • Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects.

In the event of exposure to chemical emissions:

  • The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects.
  • To date, Philips has not received reports of patient impact or serious harm as a result of this issue.

What to do next?

Philips is notifying regulatory agencies in the regions and countries where affected products are available. They are providing agencies with required information related to the  projected correction. The company will replace the current sound abatement foam with a new material that is not affected by this issue. Presently, Philips is unable to confirm the repair or replacement timeframes. They will do so when this information is available.

In Australia and New Zealand, the local Philips entities (Philips ANZ) are currently engaging with the local regulatory bodies in relation to the action for Australia and New Zealand. This recall notification has not yet been classified by regulatory agencies. (e.g. Therapeutic Goods Administration TGA in Australia)

As a community service, please leave your email below and we (CPAP Online Australia) will take the initiative to send you CPAP industry updates and the details and steps needed for the recall once it becomes available from Philips in the coming weeks.

Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use.

We suggest that if your device is nearing the end-of-life age you should replace it with an alternative manufacturer such as the industry leading ResMed CPAP device as the affected Philips devices are no longer for sale.

Which products are affected by the recall?

Philips has advised that they completed a full analysis in accordance with their Quality Management System and identified all affected products with certainty and that no other products are affected outside of the list. On 14/06/2021, Philips has provided a list of the product which are and aren’t affected and we have copied it below.

Affected CPAP and BiLevel PAP Devices:

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

  • E30 (Emergency Use Authorisation)
  • DreamStation ASV
  • DreamStation AVAPS
  • SystemOne ASV4 (50 and 60 Series)
  • C Series (50 and 60 Series AVAPS)
  • OmniLab Advanced Plus In-Lab Titration Device
  • SystemOne (Q Series) (50 and 60 series)
  • DreamStation CPAP, Auto CPAP, BiPAP
  • DreamStation GO CPAP, APAP

Affected Mechanical Ventilators:

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

  • Trilogy 100 Ventilator
  • Trilogy 200 Ventilator
  • A-Series BiPAP A40 (not marketed in US)
  • A-Series BiPAP A30 (not marketed in US)

Products not affected:

  • Trilogy Evo
  • Trilogy Evo OBM
  • Trilogy EV300
  • Trilogy 202
  • BiPAP A40 EFL
  • BiPAP A40 Pro
  • M-Series
  • Omnilab (original based on Harmony 2)
  • All oxygen concentrators, respiratory drug delivery products, airway clearance products.

Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design.

This product update relates only to the Philips line up. Other brands such as the ResMed CPAP machine lineup are unaffected. If you were thinking of buying a Philips CPAP Machine, we are happy to assist you with alternatives.

You can read the official update from Philips here.

Stay In The Loop – We will send you updates from Philips regarding the recall details and other CPAP industry news.

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Robert Afshari (B.Pharm.MPS)

Robert Afshari (B.Pharm.MPS)

Robert Afshari studied a Bachelor of Pharmacy and is a member of the Pharmaceutical Society of Australia. Robert is the sleep specialist at CPAP Online Australia.