Philips Respironics Recall 2021
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URGENT: Medical Device Recall
Philips Respironics CPAP and Bi-Level PAP Devices
Sound Abatement Foam - Susceptibility to Degradation and Volatile Organic Compound Emission
Contents
Immediate Actions
Immediate Actions to be taken by You, the User: (per Phillips Respironics)
- 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 this letter.
- Register your device on the recall website www.philips.com/src-updates
- The website provides you current information on the status of the recall and how to
receive permanent corrective action to address the two (2) issues.
- The website also provides you instructions on how to locate your device Serial Number
and will guide you through the registration process.
- Call 1-877-907-7508 if you cannot visit the website or do not have internet access.
Author comments
Comments on the above by the author. Most likely your apnea is severe enough that you require continued treatment. No one is expecting an immediate response from Philips Respironics in the form of a new machine or an immediate repair/replacement of the foam. Therefore you must take action to correct the situation.
Action
- Purchase an in-line antibacterial filter (search for "antibacterial filter for cpap" on Amazon or another site) to catch any and all foam particles. Note that this will do nothing for the off-gassing.
- Purchase a new non-affected CPAP that is the equivalent or upgrade of your current machine. Word is trickling out that at least some insurance companies are allowing replacement prior to the 5-year lifetime. Call and ask, you likely will need a prescription and possibly a justification (the Do NOT use Recall) note from your doctor, again ask.
- Philips is recommending that customers and patients do not use ozone-related cleaning products.
- For questions please ask on the Apnea Board forum.
Potential Replacement Device
| Philips Respironics | ResMed |
|---|---|
| DreamStation |
|
| DreamStation Go |
|
| DreamStation ST |
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| DreamStation AVAPS |
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| DreamStation ASV |
|
What others are doing
- using an in-line antibacterial filter as a stopgap fix
- purchasing, out of pocket, a competing product, often a ResMed device
- registering with Philips Respironics Recall list
- Calling, Doctor, DME, Insurance to evaluate options.
- a few are 'de-foaming' their DreamStation products (there have been reported failures and successes)
Timeline
April 26, 2021 - potential health risks
https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.
Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. High heat and high humidity environments may also contribute to foam degradation in certain regions.
June 14, 2021 - Recall
https://www.apneaboard.com/PR-Recall.pdf
As a result of extensive ongoing analysis following this announcement, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected devices.
ResMed Response
https://www.resmed.com/en-us/other-manufacturer-recall-2021/
Information regarding Philips' recall
(Updated: July 14, 2021)
A message from ResMed's CEO:
At ResMed, the leading global manufacturer in sleep apnea therapy, we know that ongoing treatment is critical to the health and wellbeing of many millions of people around the world. In light of Philips’ recent recall and field safety notices for many of its sleep and respiratory care products, I want to reassure our patients, providers, physicians, and communities that ResMed devices are safe to use and are not subject to Philips’ recall. ResMed devices use a different material than what Philips uses in their recalled machines. Patient safety is always our ResMed team’s top priority.
We rigorously test our devices against applicable standards before we launch a new product. We reevaluate our testing when other device makers raise concerns. The information we’ve reviewed from Philips’ recall of its devices and our detailed analysis of our products’ test results confirm that ResMed devices are safe to use.
At this time of considerable increase in demand for ResMed products, we are doing everything we can to increase our manufacturing of sleep and respiratory care devices, so we can get them to the patients who need them most. We will continue working closely and communicating directly with our customers and suppliers to help serve patients worldwide.
Mick Farrell CEO, ResMed
Health Issues
As reported by Philips Respironics
These issues (degrading foam and/or off-gassing) can result in
- serious injury which can be life-threatening,
- cause permanent impairment,
- and/or require medical intervention to preclude permanent impairment.
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.
The potential risks of particulate 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 affects.
The potential risks of chemical exposure due to off-gassing include:
- headache/dizziness,
- irritation (eyes, nose, respiratory tract, skin),
- hypersensitivity,
- nausea/vomiting,
- toxic and carcinogenic effects.
There have been no reports of death as a result of these issues.
Impacted Devices
| All Devices manufactured before 26 April 2021,
All serial numbers | |
|---|---|
| Continuous Ventilator, Minimum Ventilatory Support, Facility Use |
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| Continuous Ventilator, Non-life Supporting |
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| Noncontinuous Ventilator |
|
Unaffected Products
What products are not affected and why?
Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design.
Products not affected by this recall notification (U.S. only) / field safety notice (International Markets) include:
- Trilogy Evo
- Trilogy Evo OBM
- Trilogy EV300
- Trilogy 202
- A-Series Pro and EFL
- M-Series
- DreamStation 2
- Omnilab (original based on Harmony 2)
- Dorma 100, Dorma 200, & REMStar SE
- V60 Ventilator
- V60 Plus Ventilator
- V680 Ventilator
- All oxygen concentrators, respiratory drug delivery products, airway clearance products.
Successful Replacements
Medicare/Medicaide
- Medicare.gov Live Chat - Live Chat with Medicare Agent (7/6/2021) "Yes you can get a replacement, as long as your supplier knows that the one you have is on recall."
- United Healthcare - Medicare Advantage PPO policy (7/14/2021). (Call, Confirm, 3-way with DME). Status Awaiting ResMed restock.
Out of Pocket
- Many out-of-pocket purchases of non-Philips Respironics machines.
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