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Philips Respironics Australia and New Zealand Update 2021


 

19 June 2021

 

The Therapeutic Goods Administration (TGA) has now advised the following information replaces the previous information provided by Philips.

This has been copied directly from this webpage

 

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.

 

 

 

Previous Update

 

30 April 2021

 

Philips has provided an important update regarding proactive efforts to address identified issues with a component in certain products of their Sleep & Respiratory Care portfolio.

 

Philips has determined from user reports and testing that sound abatement foam used in a number of Philips sleep and respiratory care devices may degrade under certain circumstances.

 

This occurrence may be influenced by factors including use of unapproved cleaning methods such as ozone, environmental conditions involving high humidity and temperature, and age of device.

 

To date, Philips has not received reports of serious patient harm related to this issue.

 

For more information, please visit here.