On June 14, 2021, Philips issued a voluntary medical device recall for millions of its recalled ventilator devices and sleep apnea machines. The recall is due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and NonContinuous Ventilators.
First, the sound abatement foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user. Second, the PE-PUR foam may emit certain chemicals that could be inhaled.
Research and testing done by Philips indicates that the breakdown is primarily caused by the devices being used in high heat and high humidity environments or using unapproved cleaning methods such as ozone. Philips has also indicated that breakdown is more likely to occur in devices that are more than three years old.
Philips SystemOne Q Series Ventilator Side Effects
The potential health risks of particulate exposure in defective Philips sleep apnea machines and other similar medical devices include:
- Chest pressure
- Respiratory issues
- Toxic effects
- Cancer (carcinogenic effects)
- Other health issues
Potential risks of chemical exposure due to Philips breathing machines off-gassing include:
- Sinus infection
- High blood pressure
- Toxic effects
- Carcinogenic effects
Continued use of defective sleep apnea machines could result in potential health risks, including the risk of lung cancer, permanent kidney damage, or chronic inflammation. Individuals impacted by these medical devices should consult with their physician in order to find an alternative device that is safe.
Have you received a Philips recall notification concerning the company's repair and replacement programs from the medical, and mechanical device manufacturer?
A recalled sleep apnea machine involving defective oral appliances among users could lead to life-threatening problems in those who suffered adverse health consequences. Any family of a person who died from medical complications related to a recalled machine can file a wrongful death lawsuit to recover the following compensation for:
- Past, current, and future medical bills to treat injuries
- Past and future pain and suffering, mental anguish, and emotional stress resulting from the injuries
- Lost wages and future lost earnings
- Other economic and personal injuries
- Punitive damages if the court deems the defendant's behavior as egregious
Why People Use Home Ventilators to Treat Sleep Apnea
Philips ventilator machines are medical devices that help mitigate the symptoms of specific diseases like sleep apnea through breathing tubes by delivering increased air pressure into the throat to prevent an airway collapse during inhalation.
These devices treat respiratory failure but do not involve intubation and can be used at home by patients suffering from sleep disorders.
The user places a mask over their nose or mouth to seal off any other air sources, preventing them from inhaling oxygen unless they take minimum ventilatory support with each breath.
Philips sleep apnea machines effectively manage two primary, chronic diseases: Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). Long-term users may suffer from either condition, but most have OSA, which is more commonly referred to as sleep apnea.
These machines can also be helpful for acute conditions such as asthma, pneumonia, pulmonary edema due to congestive heart failure, and other problems that cause shortness of breath.
The Philips sleep apnea machines may also be used for short periods by individuals suffering from various acute diseases. However, long-term (chronic) users typically suffer from OSA or Chronic obstructive pulmonary disease (Emphysema).
Why is PE-PUR Foam Dangerous?
PE-PUR foam is generally not harmful if it remains intact. However, if the foam breaks down, it can release particles and chemical gases which can be harmful to someone using the device.
Break down of the foam may result in particles and chemicals being released into the device’s air pathway which the user may inhale or swallow. Even if there are no visible particles, the foam could release harmful chemicals which are then inhaled.
Philips discovered emissions of two toxic gases, dimethyl diazine and Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl)-, that exceeded the safe exposure threshold during laboratory testing. The potential risks of particulate and chemical exposure include irritation to eyes, skin and respiratory tract as well as inflammatory response, headache, asthma, adverse effects to other organs such as the kidney and liver as well as other toxic or carcinogenic effects.
To date, Philips has received complaints about the presence of black debris/particles within the device’s air pathway. Philips has also received reports of headache, upper airway irritation from continuous positive airway pressure, cough, chest pressure, and sinus infection. However, there have been no reports of death as a result of these issues.
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What Does the FDA Say About the Philips Recall?
The FDA has identified this as a Class I recall which is the most serious type of recall. The FDA is continuing to work with the company to assure it has sufficient evidence to support the Philips recall strategy, including its corrective actions.
As a medical device manufacturer, Philips is responsible for ensuring the manufacture of safe and effective devices as well as establishing an appropriate mitigation strategy to reduce public harm in the event of device failure or defect. Philips has indicated that it will replace the current insulation foam with new material.
A timeframe for device replacement has not yet been set. The FDA is currently reviewing the information Philips Respironics has provided regarding replacement devices while continuing to work with Philips Respironics on their corrective actions for existing devices. The FDA will then determine whether the proposed replacement devices pose any additional risk to people who use these devices.
Verdicts and Settlements
The recent recall lawsuit has gotten lawyers focused on recalled sleep apnea devices, how they work, and the risks associated with them. Below are summaries of settlements and verdicts in recent lawsuits:
South Carolina: $485,000 Settlement
An 80-year-old man was initially hospitalized for a foot infection. He was outfitted with a recalled Philips sleep apnea machine and a pulse oximeter. Three weeks later, the man was found unresponsive. He suffered cardiac arrest for 10 minutes, an anoxic brain injury, and oxygen deprivation.
The man never regained consciousness. His family hired a lawyer and alleged that the hospital staff’s negligence caused his death. They claimed they failed to monitor and respond to the recall and pulse oximeter alarms in a timely manner. The lawsuit ultimately settled for $485,000.
Louisiana: $300,000 Verdict
A 58-year-old obese man presented to the hospital with severe lumbar pain. The hospital staff suspected a spinal abscess. The man underwent an MRI. During the procedure, he stopped breathing. A pulmonologist and ER physician attempted unsuccessfully to resuscitate him, and the man died as a result.
His family alleged negligence against the hospital, claiming the staff failed to appreciate the fact that the man was recall dependent before positioning him for the MRI. The family argued that they should have intubated him, and a jury found the hospital negligent but not the pulmonologist. They were awarded $300,000.
Ohio: $1,200,000 Settlement
A 76-year-old woman felt ill while undergoing an MRI. The MRI facility staff called 911, and the woman became unresponsive after going into cardiopulmonary arrest in the ambulance. The Emergency Medical Technicians (EMTs) performed CPR, but the woman died of an anoxic brain injury.
The woman’s family alleged negligence against the City of Columbus, claiming that the EMTs failed to properly address her respiratory distress. The family argued that they should have used a recalled machine and administered furosemide and albuterol. The case settled for $1,200,000.
Alabama: $15,000,000 Verdict
A 45-year-old woman underwent a cardiac bypass. Following the procedure, she underwent ventilation. An arterial blood gas revealed mild acidosis and slightly elevated carbon dioxide levels. The woman then underwent ventilation. The anesthesiologist ordered the administration of Propofol.
The woman subsequently went into cardiac arrest. An ER physician attempted to resuscitate her with high adrenaline doses and closed-chest massages. The woman died several minutes later. Her family alleged negligence against the hospital. They claimed its staff administered a high Propofol dose, failed to mechanically ventilate her, improperly monitored her, and failed to call for additional help. The jury awarded $15,000,000.
Massachusetts: $1,200,000 Settlement
A 60-year-old man with sleep apnea underwent a knee replacement. He suffered no complications. Following the procedure, the man treated his pain with epidural analgesia, Dilaudid, and Nubain. He eventually underwent doses of Oxycontin, Bupivacaine, Neurontin, and Dilaudid.
The following day, the man could not move. He received a continuous positive motion device applied to at least one of his legs. The sleep apnea machine was not turned on while the man slept. He was not breathing 30 minutes after falling asleep. The hospital staff attempted unsuccessfully to resuscitate him.
His family alleged that the hospital staff’s negligence caused his death. They claimed that the staff failed to turn on the man’s sleep apnea machine and appreciate his sleep apnea risk. The defense disputed whether failing to turn on the device violated the standard of care. This case settled for $1,200,000.
Do I Qualify to Participate in a Lawsuit?
Individuals who suspect that their mechanical ventilator respiratory medical devices (Philips sleep apnea machine) have caused them injury can file a civil action against Philips to hold them accountable for the harm.
However, potential plaintiffs in lawsuits must meet specific criteria to participate in a lawsuit, including:
- They must have used a Philips sleep apnea machine, Philips Bi-level positive airway pressure PAP, or another qualifying Philips ventilator
- A qualified doctor must have accurately diagnosed their condition, including liver cancer, kidney cancer, lung cancer, heart problems, sudden respiratory failure, or other injuries.
- They are not currently or previously a smoker.
Although Philips has recalled their products to save lives, it may be too late for many home ventilator users who have already been injured by a defective sleep apnea machine.
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The Medical Device Litigation Group at our law firm is an experienced team of lawyers that focus on the representation of plaintiffs in lawsuits. Our Personal Injury Lawyers are handling individual litigation nationwide and currently accepting new cases in all 50 states.
If you or a loved one was diagnosed with cancer after using a recalled Philips sleep apnea device, or ventilator machine, you should contact our law firm immediately. You may be entitled to financial compensation for medical expenses by filing SystemOne Q Series Lawsuits and our lawyers can help you receive fair compensation.