On June 14, 2021, Philips announced a recall notification for some of their Bi-Level Positive Airway Pressure (Bi-Level PAP or BiPAP), Continuous Positive Airway Pressure (CPAP), Automatic Continuous Positive Airway Pressure (Auto CPAP), and mechanical ventilator devices normally used in hospital settings.
Philips is one of the largest manufacturers of CPAP/Auto CPAP/BiPAP devices and therefore many people who use these types of devices will likely be affected by the recall.
Philips has determined from testing that the polyester-based polyurethane (PE-PUR) sound abatement foam used to reduce the noise of the machine may be harmful to those who use it. The sound abatement foam can cause issues when it breaks down inside the machine and is breathed in. Another potential issue is that the foam may “off-gas” harmful chemicals.
Potential Side Effects
While Philips hasn’t received any reports of deaths due to foam degradation or injuries due to chemical off-gassing, there are some side effects that you might experience from foam degradation or chemical off-gassing include:
- Irritation (skin, eye, and respiratory tract)
- Upper airway irritation
- Chest Pressure
- Sinus infection
- Inflammatory response
- Adverse effects to other organs (e.g., kidneys and liver)
- Toxic carcinogenic effects
If you are experiencing these side effects, please make an appointment with your doctor right away. If these side effects were caused by a Philips sleep apnea machine, you may be eligible for compensation from Philips.
Which Machines Are Affected in the Philips Recall?
Philips states that the majority of the affected devices in the recall are in the first-generation DreamStation product family. Specifically, the following machines are included in the recall for CPAP, Auto CPAP, and BiPAP machines:
- E30 (Emergency Use Authorization)
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C Series ASV, S/T, AVAPS
- OmniLab Advanced Plus In-Lab Titration Device
- SystemOne Q series
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation GO CPAP, APAP
- Dorma 400, 500 CPAP
- REMStar SE Auto CPAP
To see the full list of mechanical ventilators, normally used in hospital settings, included in the recall, click here (LINK TO MAIN PAGE).
What Should You Do If You Use a Philips CPAP, BiPAP, or ventilator machine affected by the recall?
If you use a Philips sleep device listed in the recall, you should do the following:
- For patients using BiPAP and CPAP machines mentioned in the recall: Stop using the affected device and speak to your doctor and your Durable Medical Equipment (DME) provider to figure out other options to continue treatment.
- For patients using affected life-sustaining mechanical ventilator devices: Do NOT stop or alter using the device until you talk to your doctor.
What is Philips Doing to Resolve the Issue?
Philips will replace the affected foam with a new material not affected by the issue. Devices listed in the recall will either be replaced with a new or refurbished unit with the new material or repaired to replace the sound abatement foam. The new material will also be used in all new, future products.
What Are Your Next Steps if You’ve Been Injured by a Philips Sleep Device in This Recall?
Your first step should always be to make an appointment to discuss your symptoms with your doctor. Once you’ve been evaluated, you might be wondering what’s next. Can you be compensated for your injuries due to the Philips recall? You may in fact be eligible for compensation due to this recall.
To find out if you qualify and discuss your legal options, contact us at 800-797-5391 or fill out our contact form so that we can contact you to learn more about your situation.
For more information about the recall, click here.
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