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Important Notice: Voluntary recall by Philips for certain PAP devices

 

This notice from SleepMS|Dr. Alex Clerk’s Office contains an important health and safety update. Please read this notice in its entirety.

 

Philips has issued a voluntary recall for specific Philips Respironics CPAP, bilevel PAP, and mechanical ventilator devices. The recalled machines include the DreamStation devices that are used to treat obstructive sleep apnea. (The newer DreamStation 2 is not affected.) Philips has begun a process to repair and replace affected devices. How long this process will take is unclear.

 

The recall is related to the type of foam used to reduce the noise made by the devices. Over time, the foam inside the machine may fall apart into black particles. These particles can enter the humidifier,

tubing and mask. As a result, you may inhale the particles when using the device. Testing by Philips also found that the foam can produce unsafe chemical levels. These “volatile organic compounds” are released as gases.

 

Philips reports that the potential risks to you include:

  • headache

  • skin or eye irritation

  • asthma

  • irritation of the airway

  • nausea or vomiting

 

Philips reports that in 2020 the complaint rate for foam particles was low (0.03%). To date, there have been no reports of death. Philips has received no complaints related to chemical exposure.

 

What should you do if you use a Philips PAP device?

  • Visit the Philips recall webpage for current information.

  • Use the Philips registration process to look up your device serial number. Further assistance to locate your serial number can be found here.

  • Begin a claim with Philips if your unit is affected.

  • Call Philips at 877-907-7508 if you have questions about your device.

  • Philips also advises you to avoid using ozone products to clean your PAP device. Philips reports that ozone-related cleaners may help wear down the foam in the device.

  • If your recalled device is a life-sustaining mechanical ventilator:

    • DO NOT stop using the device.

    • Talk to your medical provider to discuss your options.

  • If your recalled device is a CPAP or BPAP device for sleep apnea:

    • Philips advises you to stop using the device and contact your doctor or device provider.

    • A prescription for a new PAP device by a different manufacturer is enclosed.

    • Please contact your current DME provider to fill this prescription.

 

Please contact SleepMS|Dr. Alex Clerk’s Office at admin@sleepmsinc.com, (408) 295-4532 or by using our Patient Portal for more information about this notice or to discuss your treatment options.

Frequently Asked Questions

What Happened? 

 

On Monday, June 14th, Philips Respironics issued a voluntary recall on nearly all of their CPAP, APAP, and BiPAP machines sold from 2009 until today, with some exceptions. 

Per Philips Respironics CEO Frans van Houten “We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety.” 

Per the Philips Respironics recall notice:

“We cannot stress enough that Philips is treating this matter with the highest possible seriousness, and are dedicating significant time and resources to address this issue. Our intention is to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority.

This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain, and other functions to support the correction.

We are absolutely committed to supporting the worldwide community of patients who rely on our Sleep & Respiratory Care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs.”

 

Why Did Philips Respironics Issue a Voluntary Recall?

 

Philips Respironics identified there is a risk the PE-SUR sound abatement foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. The foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation.

 

What Is the Safety Hazard Associated With This Issue?

 

Per Philips Respironics, "possible health risks include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material. High heat and high humidity environments as well as unapproved cleaning methods such as ozone, may also contribute to foam degradation.

The Philips Respironics FAQs state:

In the event of exposure to degraded foam:

  • “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 effects.”

  • “To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath 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.”

  • 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.”

 

Is This an Official Recall?

 

Yes. Per Philips Respironics, the issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria.

This recall notification/field safety notice has not yet been classified by regulatory agencies.

As this is an official recall, Philips Respironics must adhere to the regulatory requirements of a recall and specify the steps dealers, must follow to adhere to the recall. 

 

Which Philips Respironics Products Are Impacted?

 

What CPAP machines are on recall? Many of the Philips Respironics CPAP, APAP, and BiPAP machines sold from 2009 onward except the DreamStation 2 used this type of sound abatement foam and are impacted by this recall.

 

List of Philips Respironics CPAP Machines Recalled in 2021

 

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

E30 (Emergency Use Authorization)

Continuous Ventilator, Non-life Supporting

DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C Series ASV, S/T, AVAPS
OmniLab Advanced Plus In-Lab Titration Device

Non-continuous Ventilator

SystemOne (Q Series)
DreamStation (CPAP, Auto CPAP, BiPAP)
DreamStation Go (CPAP, APAP)
Dorma 400, 500 CPAP
REMstar SE Auto CPAP

Continuous Ventilator

Trilogy 100 Ventilator
Trilogy 200 Ventilator
Garbin Plus, Aeris, LifeVent Ventilator

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A-Series BiPAP Hybrid A30 (not marketed in the US)
A-Series BiPAP V30 Auto Ventilator

Continuous Ventilator, Non-life Supporting

A-Series BiPAP A40 (not marketed in the US)
A-Series BiPAP A30 (not marketed in the US)

How Do I Know if My Device Was Recalled?

The best way to know if your device is included in the recall is to register your machine for the recall. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number.

 

To register your device and check if your machine is included in the recall:

  1. Locate the serial number of your device. The label on the bottom of the unit features a series of letters and numbers that follow the SN or S/N on the label. If you need assistance finding your serial number, you can use this handy guide.

  2. Go to Philips Respironics recall website.

  3. Complete the registration form. Provide your information such as your name, address, and phone number so Philips Respironics can contact you regarding this recall. Be sure to use your current personal information, regardless of the information you provided at the time of purchase.

  4. Watch for confirmation. Once you’ve completed your registration, if your machine is not included, you will see a message saying your device is not included in the recall. If your machine was included in the recall, you will receive a registration confirmation number as well as important recall updates from Philips Respironics. Please be sure to save the confirmation number provided for your records. Along with your confirmation number, you will receive information about the next steps in the recall process from Philips Respironics. 

Should you continue using your machine if it is on the recall list? 

According to Philips Respironics:

  • For patients using affected BiLevel PAP and CPAP devices: Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification.*

  • For patients using affected life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes 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 identified in the recall notification.*

*  This is a recall notification for the US only, and a field safety notice for the rest of the world

 

Here is the American Association of Sleep Medicine’s guidance to patients regarding the recall. 

If you continue using your device, please note that ozone is referenced by Philips Respironics as a potential contributing factor to degraded foam. 

Additionally, Philips Respironics suggests patients review the age of their devices, as they are typically recommended to be replaced after five years of use.

SleepMS | Dr. Alexander Clerk's Office

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455 O'Connor Drive, Suite 110 
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