Philips CPAP, Bi-Level PAP and Ventilators Machines Recalled Due to Cancer Risks
On June 15, 2021, the FDA announced that Philips has initiated a recall of over 3,400,000 sleep apnea machines, also known as Continuous Positive Airway Pressure (CPAP) machines and ventilators, due to serious health risks. The Dutch medical equipment company initiated the recall because certain ventilators and breathing devices are made with a foam part that may degrade and produce a toxic gas that potentially causes cancer.
The foam part is used to dampen the sound of the machine. However, it has been discovered that the sound deadening material “degrades and emits small particles that irritate airways.” In a separate release to physicians, Philips stated that the foam may be in the process of breaking down, but show no signs of visible particles being released. Phillips’ recall announcement states that the gases discharged by the degrading foam might carry cancer risks.
Philips identified these “potentially harmful chemicals” as:
- Toluene Diamine
- Toluene Diisocyanate – Diethylene glycol
In addition, the report from Philips identified two additional “compounds of concern” (COC) could be emitted from the degrading foam that are also above the safety thresholds:
- Dimethyl Diazine
- Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl)-
Toxicological risk assessment shows that the levels of Dimethyl Diazine and Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl)- exceed the safe exposure thresholds. Philips’ report to physicians states that the company warns doctors of the following risks:
- These chemicals can cause airway inflammation, which is particularly dangerous for patients who have reduced cardiopulmonary reserve or underlying lung illnesses and diseases.
- The possible risks associated with exposure to the aforementioned chemicals include headaches, dizziness, hypersensitivity, nausea/ vomiting, irritation (to the nose, respiratory tract, eyes, and skin), toxic side effects, and carcinogenic side effects. Currently, Philips believes there have not been any fatalities caused by the chemical exposures.
To date, Philips has received no reports of patient harm resulting from these types of safety issues alleged to be related to chemical emissions.
Philips is urging customers of the recalled machines to stop using the machines. Philips reported that approximately two-thirds of its CPAP machine sales are in the United States.
Who May Be Affected By These Products?
Philips’ recall announcement states that people who have sleep apnea are at the greatest risk of having one of the recalled CPAP or Bi-level PAP machines. Also, patients who are utilizing a ventilator to assist with breathing due to health issues may have a device that is subject to the recall. According to our firm’s research, 50,000 New York 9/11 first responders, residents and workers are currently using these types of breathing devices.
Did you or a loved one use a recalled Philips CPAP machine or ventilator and receive a cancer diagnosis?
Parker Waichman LLP helps victims and families receive justice and full monetary compensation for harm caused by dangerous products. For your free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
Philips CPAP, Bi-level PAP, and Ventilator Recall Information
According to Philips’ Chief Executive Frans van Houten, Philips is one of the largest sleep apnea machine and ventilator manufacturers. The company estimates that between 3 million and 4 million units are targeted in this recall. Frans van Houten also stated that as a consequence of the recall and the corresponding corrective action that must be taken, the company wouldn’t be able to serve new customers and there would be a shortage of CPAP machines and ventilators in the field.
Philips’ spokesman, Steve Klink, stated further that approximately 80 percent of the recalled devices are Continuous Positive Airway Pressure (CPAP) machines that are used to assist patients who suffer from sleep apnea. All users of those Philips CPAP machines have been urged to stop using the machines.
Philip’s ventilators make up the other 20 percent of affected machines. The company has directed both doctors and individuals who are using life-sustaining ventilators to determine if the potential health risks from the foam outweigh the risk of not using a ventilator.
Spokesman Klink stated that Philips had received a few complaints about the machines. The complaints received so far represent about 0.03 percent of those machines sold in 2020. The company’s statement also reported that they had received reports of “possible patient impact due to foam degradation.” However, Philips maintains that they have not received reports of death as a result of the issues.
Philips also stated that it has been working with health officials to manufacture a safe replacement for the foam. However, the company must clear testing and regulatory hurdles before issuing the repairs to customers.
Philips believes the total cost of the recall and repair to reach 500,000,000 euros or about $606,000,000. Mr. Van Houten indicated that Philips is going to put all their focus on repairing and replacing the recalled units. He estimates that the process will take about one year to complete.
Lawsuits Filed Against Philips
June 21, 2021 – Lawsuits filed against Philips, a Dutch medical equipment manufacturer, assert that Philips’ recalled sleep apnea machines, including Continuous Positive Airway Pressure (CPAP) and Bilevel Positive Airway Pressure (BiPAP) machines, and ventilators may increase the users’ chance of developing pulmonary fibrosis, cancers, and respiratory issues caused by degrading parts that release toxic and carcinogenic fumes. The lawsuits allege that Philips recalled the breathing machines because of “serious injury which can be life-threatening or cause permanent impairment,” and the company was aware of the risks for several years, but did not disclose the hazards until April 2021. The Complaint states that customers complained to Philips concerning black particles in their machines for several years, but Philips did not issue a recall until June 14, 2021.
The lawsuits are demanding that Philips compensate the complainants with a full refund of the product’s purchase price paid, a non-defective machine replacement, all medical costs and medical monitoring costs associated with recalled device, and all related damages for injuries sustained as a result of using the defective Philips Dreamstation, and legal fees.
The affected Philips Dreamstation and breathing machines were constructed with a polyester-based polyurethane (PE-PUR) foam. PE-PUR foam has been shown to break down and may be accidentally ingested or inhaled. Moreover, PE-PUR foam can release volatile organic compounds (VOCs) causing serious, adverse effects to organs, and may cause certain types of cancer. Philips reported that the company “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’ flagship BiPAP and CPAP machines are called the “DreamStation” line. Philips also sells its DreamStation products through its subsidiary Respironics. Respironics was acquired by Philips in 2008.
Lawsuits filed against Philips also allege that Philips was acting in a self-servingly manor when it timed its recall of affected breathing machines with the company’s launch of its next generation of CPAP lineup. The new line of breathing machines are not made with the same polyester-based polyurethane (PE-PUR) foam. Therefore, Philips could offer its customers a newer model, while boosting the company’s profits. The recall leaves customers without safe, free alternatives and they will be forced to purchase Philips’ next-generation breathing machines or a competitor’s machine at full price.
FDA Reclassifies Positive Airway Pressure Delivery Systems from a Class III Medical Device to a Class II Medical Device
According to aasm.org, the U.S. Food and Drug Administration (FDA) reclassified positive airway pressure (PAP) delivery systems from a Class III medical device to a Class II medical device on October 19, 2018. The PAP delivery systems will continue to require a prescription to purchase and use. Typically, the FDA classifies medical devices based on the risks associated with the medical device and, after assessing the amount of regulation necessary to provide a sensible presumption of the medical device’s effectiveness and safety.
Class I medical devices ordinarily pose the lowest danger to the patient, while Class III medical devices pose the greatest hazard risk to patients. The principal goal of reclassification is to apply a suitable amount of regulatory controls for a medical device type based on the most up-to-date information concerning its safety and effectiveness.
All medical devices not in commercial distribution before May 28, 1976, are automatically classified as Class III medical devices. Class III medical devices require premarket approval until or unless the FDA reclassifies or classified the medical device. The FDA initiated the PAP reclassification after receiving a request from FRESCA Medical for de novo classification of its CURVE PAP system. According to federal regulations, reclassification is applied to a distinct device type and not to individual devices.
The FDA maintains that placing PAP devices into a lower medical device class patients will benefit by having access to beneficial innovations by reducing regulatory impediments. The special controls specified by the FDA for the reclassification of the PAP delivery system to Class II include:
- The device’s patient-contacting components must be shown to be biocompatible.
- Non-clinical performance test results must show that the medical device performs as intended, while under anticipated conditions of utilization, including:
- Waveform tests must simulate breathing conditions, evaluate pressure, and airflow response rates over a combination and range of low and high breath rates, as well as tidal volumes.
- Use life tests are required to prove adequate device performance over the stated use life of the medical device.
- Device integrity tests are required to show that the medical device is able to withstand the usual forces that happen during use.
- A carbon dioxide rebreathing tests must be performed and reported.
- The device’s system flow rate, inhalation pressure, maximum expiratory pressure, and intra-mask static pressure tests are to be performed and reported.
- Air bolus testing must show that the medical device can withstand all worst-case scenario air pressures.
- A maximum limited pressure test of the flow generator that is in a single fault condition must be performed and results reported.
- A maximum output temperature test of delivered gas, if the gas is humidified, must be performed and results reported.
- Performance data must validate reprocessing instructions for any reusable components of the device.
- Performance data show the thermal, electrical, and mechanical safety and the electromagnetic compatibility of the medical device.
- The device’s software must undergo verification, validation, and hazard analysis needs to be performed and reported.
- Product labeling must include:
- Therapy pressure range;
- The use life as well as the replacement schedule for all of its components;
- Cleaning instructions; and
- Assembly and device component connection instructions.
According to the FDA regulation, a PAP delivery system “is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.”
Which Philips CPAP, Bi-Level PAP, and Ventilator Devices Are Being Recalled?
|All Recalled Devices That Were Manufactured Before 26 April 2021, All Device Serial Numbers|
|Continuous Ventilator, Minimum Ventilatory Support, Facility Use||E30 (Emergency Use Authorization)|
|Continuous Ventilator, Non-life Supporting||DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4 C-Series ASV
C-Series S/T and AVAPS
|Noncontinuous Ventilator||SystemOne (Q-Series)
DreamStation Go Dorma 400
Dorma 500 REMstar SE Auto
|Continuous Ventilator||Trilogy 100
Garbin Plus, Aeris, LifeVent
|Continuous Ventilator, Minimum Ventilatory Support, Facility Use||A-Series BiPAP Hybrid A30 (not marketed in the US)
A-Series BiPAP V30 Auto
|Continuous Ventilator, Non-life Supporting||A-Series BiPAP A40 (not marketed in the US)
A-Series BiPAP A30 (not marketed in the US)
According to Philips, the following medical products are not being recalled. The following units are not being recalled because these products were manufactured with a different sound abatement foam material and some units were also designed differently.
The following products are not being recalled:
- Trilogy Evo
- Trilogy Evo OBM
- Trilogy 202
- A-Series Pro and EFL
- DreamStation 2
- Omnilab (original based on Harmony 2)
- Dorma 100, Dorma 200, & REMstar SE
- All oxygen concentrators, respiratory drug delivery products, airway clearance products.
FDA Publishes New FAQs Concerning Philips’ Respironics Ventilator, CPAP, and BiPAP, and Ventilator Recalls
Philips Respironics has issued a recall of approximately 2 million breathing machines due to sound abatement foam breaking down and may break down and potentially release toxic particles and fumes into the user’s air pathway. The recall affects Philips’ certain ventilators, continuous positive airway pressure (CPAP) machines, and bi-level positive airway pressure. The polyester-based polyurethane (PE-PUR) sound abatement foam that is supposed to reduce vibration and sound in the recalled devices can deteriorate and release toxic and potentially carcinogenic chemicals into the unit’s air pathway causing toxic particles and gases to be swallowed or inhaled by the individual using the device.
Philips’ Breathing Machine Recall Frequently Asked Questions
Question: When will Philips replace or repair the recalled machines?
Answer: Philips Respironics has already begun the process of replacing some of the first-generation DreamStation CPAP breathing machines with DreamStation 2 CPAP devices and anticipates the repair and replacement programs will be finished in 12 months.”
Question: Which Philips Respironics machines are being repaired or replaced?
Answer: The FDA has reviewed and accepted Philips’ Respironics plan to recall and repair or replace its DreamStation CPAP and BiPAP machines. The affected models included Philip’s DreamStation CPAP; Pro, Auto (All Configurations), DreamStation ST, ASV, AVAPS (All Configurations), and Dream Station BiPAP; Pro, and Auto (All Configurations).
Philips Respironics has not furnished the FDA all of the information the agency needs to evaluate Philip’s plan to repair and replace all of the Philips Respironics’ recalled devices, including the A-series BiPAP machines, Trilogy ventilators, OmniLab Advanced+, C-series BiPAP machines, Aeris, Garbin Plus, LifeVen, REMstar SE Auto, E30 ventilator, and E30.
The FDA also began on-site inspections of Philips Respironics’ manufacturing facilities to evaluate the company’s compliance with the agency’s regulatory requirements.
Question: Will Philips Respironics be fined or receive any type of enforcement action over the company’s handling of the recalls?
Answer: If Philips Respironics action is not complete or rapid, the FDA may take enforcement action. The FDA classified the recall is a Class I recall, which is the most severe kind of recall. The FDA will work with Philips to assure that the company has provided enough evidence showing the safety and effectiveness of the company’s proposed efforts to address the products’ defect.
The FDA has also initiated on-site inspections of Philips Respironics’ manufacturing centers to assess the company’s compliance with the regulatory requirements.
Question: Are the product codes for the Philips BiPAP and CPAP machines on the FDA’s device shortage list?
Answers: Yes, all the product codes for Philip’s CPAP and BiPAP machines have been placed on the machine shortage list due to device availability problems. These include product codes NOU, BZD, CBK, MNS, and MNT. A majority of the recalled devices are categorized under product code BZD.
Question: What medical devices are recalled?
Answer: Philips Respironics announced recalls of their medical devices due to the risk of exposure to toxic and carcinogenic debris and chemicals that may cause health risks from PE-PUR sound abatement. The FDA’s Safety Communication concerning the recalled breathing machines identified which Philips Respironics Ventilators, CPAPs, and BiPAP machines have been recalled due to the potential health risks.
Philips Respironics also recalled other ventilators, which the FDA identified as a Class 1 recall but is not related to the sound abatement PE-PUR foam issue. In a separate Philips Respironics Recall, V60 and V60 Plus Ventilators that are equipped with the company’s High Flow Therapy Software Versions 3.00 and 3.10 were recalled after it was discovered that there was a risk of receiving reduced oxygen.
Question: What can patients do now if they cannot wait for a repair or replacement?
Answer: The first step is to confirm that your breathing device is part of the recall. Philips Respironics has listed all of the recalled models and provided directions on how to find out if your device has been recalled. Philips Respironics’s online registration process enables you to look up your device’s serial number and to start your claim if your device is being recalled.
The FDA gave specific guidance for patients who have a recalled breathing machine in the agency’s safety communication. The safety communication also includes directions that state patients may proceed in using their affected device and to contact their doctor to see if the benefits of using the recalled device outweighs the risks as identified in the recall announcement.
Question: Should patients remove the sound abatement foam from their device?
Answer: No. The FDA patients with recalled devices to not remove the sound abatement foam because of the possibly introducing more foam debris into the device air pathways. Philips Respironics is accountable for the replacement or repair of all recalled devices.
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Parker Waichman LLP is a nationally recognized law firm that has built an impressive reputation for winning significant jury awards and verdicts against large medical device corporations. Defective medical device lawsuits are rigorously defended by top-level defense attorneys who have sizeable legal defense budgets. However, Parker Waichman LLP has successfully recovered more than $2 billion for injury victims and the families of those who lost their lives due to dangerous medical products.
The trial attorneys and legal support staff at Parker Waichman LLP are incredibly proud of the results our firm has obtained for our clients. Very few plaintiffs law firms have recovered more than $2 billion in settlements, jury awards, and verdicts. Our firm has also received numerous awards and accolades for quality legal representation, including top ratings on AVVO’s Attorney Rating System and a listing as in Martindale-Hubbell’s top “AV Peer Review Rating.”
CONTACT PARKER WAICHMAN LLP FOR YOUR FREE CASE REVIEW
At Parker Waichman LLP, our medical equipment injury attorneys handle the most challenging plaintiff cases, and we fight hard to recover full monetary compensation for our clients. If you or a loved one have developed cancer and were using a recalled ventilator or CPAP machine manufactured by Philips, contact our law firm today to receive your free consultation. Call us today at 1-800-YOURLAWYER (1-800-968-7529) or use our Live Chat to receive your free consultation.
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