Royal Philips has issued a “recall notification to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices.”
The recall applies to certain Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices.
Why the recall from Philips?
Philips learned that the polyester-based polyurethane (PE-PUR) “sound abatement foam” used in the affected products can degrade, posing health risks to affected patients.
According to its statement, “Philips determined based on testing that there are possible risks to users related to this type of foam. The risks include that the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals.”
Who is affected by the recall?
Philips states that is has produced millions of Bi-Level PAP, CPAP and mechanical ventilator devices using the PE-PUR sound abatement foam. Presumably there is a very wide group of patients who may have been treated with affected devices.
What are the injuries caused by the Philips sound abatement foam?
Philips’ press release statement on possible injuries includes:
“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.”
A more detailed statement, here, includes the following injuries:
“Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects.”
As plaintiffs’ lawyers, our antennae are up at the vague phrase “carcinogenic effects.” What does this mean? How is a “Carcinogenic effect” different from simply “cancer”? Has Philips received a complaint of cancer? Note that their statement strongly asserts “there have been no reports of death” but continues to state “Philips has received reports of possible patient impact.” What sort of “impact?” These are questions that future litigation–read: Philips ventilator lawsuits–may answer.
Which Philips ventilators are defective and dangerous?
Philips identifies the following devices as containing the dangerous and defective PE-PUR sound abatement foam:
- CPAP and BiLevel PAP Devices
- E30 (Emergency Use Authorization)
- 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
- Mechanical Ventilators
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto
- A-Series BiPAP A40
- A-Series BiPAP A30
Which Philips ventilators are NOT affected by the recall?
Philips asserts the following products are NOT affected by the recall:
- Trilogy Evo
- Trilogy Evo OBM
- Trilogy EV300
- Trilogy 202
- BiPAP A40 EFL
- BiPAP A40 Pro
- M-Series
- DreamStation 2
- Omnilab (original based on Harmony 2)
- Dorma 100, Dorma 200, & REMStar SE
- All oxygen concentrators, respiratory drug delivery products, airway clearance products.
I was treated with one of the recalled devices, what should I do?
If you or a loved one was treated with one of the dangerous and defective Philips ventilator machines, contact the defective medical device attorneys at David Randolph Smith & Associates today. Our experienced products liability attorneys can help you get the answers you deserve.
