Philips Breathing Devices Foam Defect May Cause Cancers, Lung Diseases, Kidney and Liver Failures, Other Serious Medical Conditions
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The Law Offices of Thomas J. Lamb represents people who have been harmed by unsafe medical products, including cases that involve the June 2021 Philips breathing devices recall.
June 2021 Recall of Philips Bi-Level PAP and CPAP Devices, Mechanical Ventilators
In June 2021 Philips Respironics issued a product recall for certain Philips Bi-Level PAP devices, Philips CPAP machines, and Philips Mechanical Ventilators due to possible toxic exposures from the polyester-based polyurethane (PE-PUR) sound abatement foam component in those Philips products. This Philips breathing devices foam defect is found in many of its Bi-Level PAP devices and CPAP machines as well as Mechanical Ventilators that were manufactured between July 2009 and April 2021. Regarding patient health issues, the harmful foam problem in defective Philips devices might cause cancers, lung diseases, organ failures, and other medical conditions in patients who used these recalled Philips products in the past.
From the June 2021 Philips recall notification, we get this important information for patients:
Philips determined based on testing that there are possible risks to users related to [the polyester-based polyurethane (PE-PUR) sound abatement foam component]. The risks include that the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. [emphasis added]
In this document, “Medical Device Recall Notification — Philips Respironics Sleep and Respiratory Care devices“, Philips Respironics provides some product identification information about the various Philips Bi-Level PAP devices (also known as BiLevel PAP, BiPAP, or BPAP), Philips CPAP machines, and Philips Mechanical Ventilators covered by this June 2021 Philips products recall — as well as what Philips products are not covered by this June 2021 Philips recall, and why.
On June 30, 2021, the FDA issued this document to alert and inform patients, “Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication“, which lists the Philips breathing devices manufactured between July 2009 and April 26, 2021 that are covered by the June 2021 Philips products recall. For more information from this June 2021 FDA document about the Philips breathing devices recall, see our report: “FDA Safety Alert about Philips Recall of Ventilators, BiPAP, and CPAP Machines“.
Products Liability Lawsuits Against Philips for Personal Injury and Wrongful Death
Our law firm is investigating lawsuits against Philips for patients who have been diagnosed with cancer, lung disease, and kidney or liver failure, as well as other medical conditions, following their use of these recalled Philips products:
- Philips Bi-Level Positive Airway Pressure (Bi-Level PAP) Devices
- Philips Continuous Positive Airway Pressure (CPAP) Machines
- Philips Mechanical Ventilators
Most Recent Article on This Topic
Philips Ventilators Recall: What The Company Knew and When, What It Did or Did Not Do, and More FDA Findings Released November 2021
This is an important update about the June 2021 Philips ventilators recall using some remarkable findings set forth in an FDA Form 483 issued to Philips Respironics on November 9, 2021.
First, from a November 16, 2021 article, “FDA inspection turns up more problems for Philips Respironics”, published on the Regulatory Affairs Professionals Society (RAPS) site, about FDA Form 483 issued in connection with the Philips ventilators recall:
The investigation also found that Philips had ignored earlier red-flag signs that foam was breaking down and entering the breathing tube of their products, with executive-level managers having been aware of “potential foam degradation issues concerning CPAPs, BiPAPs and Trilogy ventilators since at least 1/31/2020,” wrote FDA investigator Katelyn Staub-Zamperini.
Second, a November 15, 2021 article, “FDA Inspection of a Philips Facility Raises Red Flags”, published on the Medical Device and Diagnostic Industry (MD+DI) site, covers the critical point that the FDA’s findings suggest that Philips Respironics had known for several years about the potential foam degradation issues that gave rise to the June 2021 Philips ventilators recall. We get this excerpt from the “Philips knew about the foam degradation problem 6 years ago” part of that MD+DI article:
To read more of this article, click below:
The investigator’s report also points out that around Nov. 25, 2015, Philips was aware of a preventative maintenance servicing procedure implemented by another Philips entity on Trilogy ventilator products regarding foam degradation issues and complaints in the field. However, Philips Respironics either did not perform or did not document any further investigation, health hazard evaluation, risk analysis, or design review of the issue. The company did, however, provide the investigator with an email that the other Philips entity sent on Nov. 25, 2015, detailing the preventative maintenance procedure and timeline.
Third, from a November 15, 2021 article, “Damning FDA-483: Philips Didn’t Investigate 222,000 Complaints Of Possible Degraded Foam In Breathing Devices”, written by Shawn M. Schmitt for Medtech Insight:
In one of the more damning observations made by investigator Katelyn Staub-Zamperini during the 26 August-9 November inspection, Philips apparently opened no formal investigations after it received hundreds of thousands of complaints of particles and other contaminants when the devices were used.
Our law firm is investigating Philips ventilators recall lawsuits for patients who have been diagnosed with cancer, lung disease, and kidney or liver failure, as well as other medical conditions.
If you or someone you know used one of the recalled Philips Bi-Level PAP, Philips CPAP, or Philips Mechanical Ventilator devices and, in turn, developed cancer or experienced organ failure, we are providing free case evaluations for possible lawsuits against Philips.[Read article in full at original source]
Our earlier articles about this Philips breathing devices recall situation:
- Philips Breathing Devices Recall Update: FDA Releases Explosive New Findings in November 2021
- Philips CPAP and BiPAP Replacement Foam May Continue to Cause Issues
- Philips Faces Lawsuit from SoClean Inc. Over Its Statements About Use of Ozone Cleaners in CPAP and BiPAP Machines
- Philips Brand Breathing Devices Part of June 2021 Product Recall
- Products Recall: Philips Bi-Level PAP, CPAP, and Mechanical Ventilator Devices Using PE-PUR Sound Abatement Foam