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Posted on 02 Jul 2021
Incident response/review

Urgent product defect correction

The Therapeutic Goods Administration (TGA) has issued a product defect correction for certain Philips Electronics CPAP, Bi-Level PAP devices and ventilator devices.

The sound abatement foam used in these devices may degrade and be ingested or inhaled by the user. There is also the potential for this foam to off-gas certain chemicals. 

The TGA has issued updated information regarding the risk posed by these devices and further guidance for users. Read more.

Advice for patients

Stopping treatment suddenly could have an immediate and detrimental effect on your health.

View a list of affected devices.

If your device is listed, please speak with your healthcare provider before making any changes to your prescribed therapy.

Together you can decide if the benefit of continuing therapy with the device outweighs the risks identified below, and discuss alternative long-term therapy options.

Update: Please register your device on the Philips support website. This will allow Philips to contact you to organise the corrective actions or a replacement device. 

Advice for health professionals

 

Please review the information provided by the TGA:

 

If a patient requests a review of their therapy, or they are using an affected device in your health service, please undertake a patient-specific risk assessment to determine whether the benefits of continuing therapy outweigh the risks identified below.

Potential risks

  • Headache
  • Dizziness
  • Irritation (eyes, nose, respiratory tract, skin)
  • Inflammatory response
  • Asthma
  • Adverse effects to other organs (e.g. kidneys and liver)
  • Hypersensitivity
  • Nausea and vomiting
  • Toxic and carcinogenic effects

To date, there is no definitive evidence of long-term harm and there have been no reported deaths as a result of these issues.

Background

Philips has identified two issues related to the sound abatement foam used in Philips continuous and non-continuous ventilators.

  1. The foam may degrade into particles which may be ingested or inhaled by the user. This may be exacerbated by using unapproved cleaning methods, such as ozone.
  2. The foam may off-gas certain chemicals. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the device’s life.

Where possible, Philips will replace the affected foam component in impacted devices.

Read more

Page last updated: 07 Jul 2021