Philips Respironics Sleep Apnea BiPAP/CPAP Recall
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.
The FDA has identified this recall as Class 1, meaning that use of these recalled devices may cause serious injury or death.
Philips is one of, if not the, largest manufacturers of CPAP/Auto CPAP/BiPAP devices and therefore many people who use these 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.
Who Uses CPAP/BiPAP Machines? Why?
People who have been diagnosed with sleep apnea through a sleep study by their doctor may use a CPAP, Auto CPAP, or BiPAP machine to open their airway and get enough oxygen while they sleep. Untreated sleep apnea can lead to high blood pressure, heart failure, increased risk of stroke and heart attack, and even increased risk of death.
What Side Effects Can You Experience from the Philips Sleep Apnea Device Recall?
The sound abatement foam can cause issues when it breaks down inside the machine and is breathed in through the tubing and mask by the consumer. Another potential issue is that the foam may “off-gas” harmful chemicals. This off-gassing is made even worse by what Philips calls “unapproved cleaning methods” like ozone (ex. SoClean ozone CPAP cleaner). We remind you to be wary of these products as well, and so does the FDA in a recent statement.
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 including:
- 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
Make sure to take pictures of your CPAP machine and the model number. This will ensure you have proper documentation for your claim.
The possible side effects of chemical off-gassing include:
- Irritation (eyes, nose, respiratory tract, skin)
- 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.
Chemicals of Concern in Sound Abatement Foam
The PE-PUR sound abatement foam can degrade over time and may contain diethylene glycol (DEG), dimethyl diazine, toluene diamine isomers (TDA), phenol 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl), and toluene diisocyanate isomers (TDI).
From their research, Philips determined that dimethyl diazene is emitted for the first 24 hours of recalled machine use in detectable levels. Phenol 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl), another substance of concern noted as “harmful” and “environmental hazard,” is emitted for several days of initial use of your CPAP/BiPAP/Auto PAP machine.
Which Specific Machines Are Affected in the Philips CPAP/Auto CPAP/BiPAP/Ventilator 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
Mechanical ventilators which were affected by the recall include:
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator
- A-Series BiPAP Hybrid A30 (not marketed in US)
- A-Series BiPAP V30 Auto Ventilator
- A-Series BiPAP A40 (not marketed in US)
- A-Series BiPAP A30 (not marketed in US)
Which Machines are NOT Affected by the Philips CPAP, BiPAP, Ventilator Recall?
The following Philips machines are not affected by the current recall by Philips and include:
- Trilogy Evo
- Trilogy Evo OBM
- Trilogy EV300
- Trilogy 202
- BiPAP A40 EFL
- BiPAP A40 Pro
- DreamStation 2
- Omnilab (original based on Harmony 2)
- Dorma 100, Dorma 200, & REMStar SE
- All oxygen concentrators, respiratory drug delivery products, and airway clearance products.
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. See below for what Philips is doing to resolve the issue.
- For patients using affected life-sustaining mechanical ventilator devices:Do NOT stop or alter using the device until you talk to your doctor. There may not be another option, or the options may be extremely limited for alternatives for ventilators. The doctor in consultation with the medical team and patient and/or patient’s family will weigh the risks and benefits of continued use of the affected ventilator.
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. Philips’ DreamStation 2 is not affected by the issue and does not include the affected foam from the recall.
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.
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