Urgent product defect correction advice for patients and customers
Based on the latest analysis of potential health risks, the product defect correction advises patients and customers to take the following actions:
- For patients using affected BiLevel PAP and CPAP devices: Stopping treatment suddenly could have an immediate and detrimental effect on patient health. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. While the risks identified have resulted in Philips recommending discontinued use, it is important that you consult with your physician to determine the most appropriate options for continued treatment. 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.
- For patients using affected life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. 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.
Philips has established a registration process that provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. To register affected devices, patients, users, or caregivers are advised to log onto the product correction website: www.philips.com/SRC-update.
Possible health risks
The company continues to monitor reports of potential safety issues as required by medical device regulations and laws in the markets in which it operates. To date, there have been no reports of death as a result of these issues. Philips has received reports of possible patient impact due to foam degradation. The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects. Philips has received no reports regarding patient impact related to chemical emissions.
Repair and replacement program
In Australia, Philips is working with the local regulatory agencies on the launch and implementation of the permanent corrective action.
The company will replace the current sound abatement foam with a new material and has already begun the preparations, which include obtaining the relevant regulatory clearances. While Philips aims to address all affected devices in scope of this correction, the company is currently unable to confirm the repair or replacement timeframes and will do so when this information is available.
Consumer law rights under the Australian Consumer Law are in addition to any remedy that Philips may provide.
For more information on the status of the product defect correction as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update.
*Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication.