Voluntary Recall Notice: Phillips Respironics Medical Devices

Date: June 29, 2021 Subject: Voluntary Recall Notice: Phillips Respironics Medical Devices Providers should monitor the Texas Children’s Health Plan (TCHP) Provider Portal regularly for alerts and updates associated to the COVID-19 event.  TCHP reserves the right to update and/or change this information without prior notice due to the evolving nature of the COVID-19 event.Call to action: Texas Children’s Health Plan (TCHP) would like to make providers aware of an important voluntary recall Philips Respironics has initiated for two of their ventilators and Positive Airway Pressure (PAP) devices. The issues with the devices are related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non-Continuous Ventilators. A description of the issues are as follows:

• PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user.
• The PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of Ozone cleaners), and off-gassing may occur during operation.

The affected devices include:

• Trilogy 100 and 200 Ventilators
• All CPAP and Bi-level PAP Devices Affected Devices Manufactured Before 26 April 2021:
• Dream Station ASV; Dream Station ST, AVAPS; Dream Station CPAP, AutoCPAP, BiPAP;

System One ASV4; C Series ASV, S/T, AVAPS; System One Q series; REMStar SE AutoCPAP TCHP Member’s health and safety is of the utmost importance. We are supporting manufacture and provider outreach through the following actions:

• TCHP Provider Relations is working with DME providers to review potentially impacted members.
• TCHP Care Coordination is reaching out to members who potentially have affected equipment. We are encouraging members/LARs to speak to their prescribing or ordering providers to determine next steps.
• TCHP Care Coordination is encouraging members/LARs to speak to their prescribing or ordering providers to determine next steps.
• TCHP will assist with any member needing assistance connecting with their ordering provider.

How this impacts providers: For a full description of the recall, including images of the devices, frequently asked questions, and guidance for providers, patients, and other medical personnel, click here: https://www.usa.philips.com/healthcare/e/sleep/communications/src-update#section_2. The manufacturer, Philips Respironics, has developed a process for how the ventilators will be repaired or replaced. Visit the website named above or call 1-877-907-7508, for more information on claims processing and support. Next steps for providers: Providers should actively outreach to their patient’s that utilize the ventilators and PAP devices described in this provider alert and notify them of the recall. If needed, providers can refer TCHP Member’s to contact their assigned Service Coordinator or Case Manager at 832-828-1430, or our Member Services Department at 1-800-659-5764.   If you have any questions, please email Provider Network Management at: providerrelations@texaschildrens.org.For access to all provider alerts,log into: www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers.