Published by Table Of Contents
Philips Engineer Flagged Ventilator Foam Problems Years Before Recall: Court Docs
Philips Respironics was aware of safety risks with the sound-abatement foam in its CPAP devices and knew that the foam was defective years before the company issued a formal Philips CPAP recall, newly unsealed court documents indicate.
The company initiated the Philips CPAP machines, BiPAP machines and Philips Respironics ventilators recall in June 2021, which was designated by the FDA as a Class I Recall, indicating a high risk of serious injury or death.
As of May 2022, the agency had received over 21,000 medical device reports linked to the pe pur foam abatement problem from April 2021 to April 2022, including at least 124 patient deaths from Philips CPAP and BiPAP machines.
Philips anticipated the oncoming recall in an April 2021 earnings report in which the company announced that it had set aside 250 million euros after identifying “a quality issue in a component that is used in certain sleep and respiratory care products” and beginning to make remedies against the problem.
However, documents attached to an ongoing CPAP lawsuit that involves over 100 legal actions against Philips show that the company’s knowledge of the foam problem date back years before it warned the public.
The documents include a number of email exchanges between Bob Marsh, a technical director at Polymer Technologies—a distributor of Philips’ sound-abatement foam—and Lee Lawler, then the technical director of the polyurethane foam division at William T. Burnett, the maker of the foam. In April 2018, Marsh forwarded to Lawler a message from Vincent Testa, a mechanical engineer at Philips, who wanted to know what could potentially cause the foam to degrade prematurely.
“Recently we’ve received a few complaints from our customers that the foam is disintegrating,” Testa said. “The material sheds and is pulled into certain Koninklijke Philips Respironics ventilators’ air path. As you can imagine, this is not a good situation for our users.”
While sending Testa’s note to Lawler, Marsh referenced a 2016 message in which he hadn’t identified Philips by name, but said that one of the company’s customers had received reports of the foam breaking down after 5 years of use.
The Burnett rep repeatedly stated in emails between Marsh and Lawler that a polyether foam would be better suited than the polyester foam in a warm, high-humidity environment—like the one created by Philips CPAP machines, BiPAP and ventilator machines.
“I would not be surprised if ester foam, continuously exposed to 40°C (104°F) at high humidity in recalled CPAP machines, would exhibit signs of hydrolysis in as short a time as a year,” Lawler said in 2016.
While forwarding the message, Marsh admitted that Philips had tested both polyester and polyether foams in high heat and humidity, and confirmed that polyether had performed better.
Marsh forwarded another message from Testa in May 2018 asking about the safety of continuing to use the polyester foam, but with a replacement program scheduled. Lawler advised against it, saying Burnett “would not recommend use of polyester foam in such an environment,” again stating that polyether foam would work better.
Weeks later, while passing on another message from Testa, Marsh told Lawler that Philips was “investigating alternatives to polyurethane foam (ester and ether).” Lawler later testified that he failed to reply to the request, citing the need to protect Burnett’s proprietary information.
Regardless, Philips continued to use the polyester foam. According to the June 2021 recall notice, it was still being used in auto CPAP devices manufactured as recently as April 22, 2021.
What is an AVAPS Machine?
Average volume-assured pressure support (AVAPS) is a relatively newer modality of non-invasive ventilation that integrates the characteristics of both volume and pressure-controlled non-invasive ventilation.
AVAPS is designed specifically for taking over the control of and adapting automatically to each patient’s changing therapy needs. It is a noninvasive home ventilator that provides the patient with the accurate pressure volume required to maintain adequate treatment.
AVAPS Recall
In June 2021, Philips recalled CPAP, BiPAP machines, and ventilator machines due to potential health risks, including potential cancer risks.
The recall is related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in the continuous positive airway pressure (CPAP) and BiPAP devices. The PE-PUR foam can reportedly degrade into small particles that can be inhaled or ingested, or emit chemicals that pose health risks including possible carcinogenic effects from the recalled Philips devices.
Which AVAPS Were Recalled?
Continuous Ventilator, Non-life Supporting recalled devices
- DreamStation ASV
- DreamStation ST, AVAPS Bilevel Positive Airway Pressure
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
Side Effects
Philips Respironics has received reports of possible patient impact due to foam degradation in Philips CPAP machines recalled.
The potential health risks of particulate exposure in defective AVAPS, Philips sleep apnea machine, ventilator devices, and other similar medical devices include:
- Headache
- Irritation
- Inflammation
- 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:
- Headache
- Irritation
- Hypersensitivity
- Nausea/vomiting
- Sinus infection
- High blood pressure
- Toxic effects
- Carcinogenic effects
AVAPS vs BiPAP
Although both AVAPS and BiPAP are reliable in the treatment of acute hypercapnic respiratory failure, AVAPS is associated with a speedy improvement of the patient clinically. The patients have also experienced greater comfort and satisfaction comparatively, and therefore, improved treatment compliance.
FAQs
Is there any compensation for owners of the recalled Philips AVAPS machines?
Philips is offering replacements or refunds for the affected devices. Contact their customer service for details on the compensation process.
Can I still use my Philips AVAPS machine if it hasn’t shown any issues?
It is recommended to stop using the recalled devices immediately to ensure safety, even if no issues have been observed.
How long will it take to receive a replacement or refund for the recalled device?
The time frame for receiving a replacement or refund may vary. Contact Philips customer service for specific details on processing and shipping times.
What Should I Do If I’m Using a Recalled Philips AVAPS Device?
If you or a loved one are using one of the recalled Philips AVAPS machines, Philips says you should speak with your physician to figure out the best options for continued treatment.
“Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where disruption is unacceptable,” the recall notice states. “In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilators with unapproved cleaning methods may outweigh the risks.”
The company has begun replacing the PE-PUR foam in the recalled Philips CPAP machine with new material.
Tell your doctor about any symptoms you have that may be related to the use of a recalled Philips CPAP machine.
So far, dozens of Philips CPAP lawsuits have been consolidated into a Philips CPAP MDL and sent to a Pittsburgh federal court.
Related Articles:
See all defective medical device litigations our lawyers have covered.
To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: