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After recently conducting an inspection of a Philips Respironics manufacturing facility, the US FDA released an update related to the June 2021 Class I recall of Philips Respironics CPAP, BiPaP and other ventilators.
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After the inspection, the FDA requested additional safety testing on replacement materials and issued a Form 483, which details how Philips and its foam supplier were aware for years that polyester-based polyurethane (PE-PUR) sound abatement foam could break down and potentially enter a device’s air pathway.
According to the FDA Form 483 report, the June recall may not have covered all of the breathing machines with toxic sound abatement foam. In addition, it appears the company knew about the issue years before the recall.
The FDA inspection report outlines a series of complaints, reports and emails that document the company was aware of issues with the foam degrading and continued to manufacture and sell the devices.
The FDA found emails between Philips and its raw foam supplier that showed Philips was made aware of foam degradation issues in October 2015. These issues were confirmed in 2016 by the unidentified supplier.
The Form 483 documents the inspector’s concerns, which included:
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FDA Form-483 lists observations made by the FDA representative during the inspection. They are inspectional observations and do not represent a final Agency determination regarding compliance. They do alert management of conditions that the inspector considered possible violations of the US Food, Drug and Cosmetic Act or related regulations.
Read Form-483 and these articles for more details.
Note: The FDA redacted parts of the report, citing a public records law exemption to protect trade secrets and confidential commercial or financial information; however, the redactions do not obscure the inspector’s concerns.
In June 2021, Philips Respironics announced a voluntary recall, which the FDA classified as Class 1, of certain ventilators, CPAP and BiPAP machines due to potential health risks related to PE-PUR sound abatement foam. The issue was that the PE-PUR foam could break down during usage and release toxic chemicals or debris directly into the machine’s air pathways and users lungs thus causing serious, life-threatening injuries.
After the recall, Philips developed a plan to repair the PE-PUR foam in the recalled devices with a different silicone-based foam. The plan was initially approved; however, during the inspection, the FDA obtained additional information not previously available regarding the silicone-based foam used in a similar device marketing outside the US.
An A Series CPAP containing the silicone-based foam the company is using to repair the recalled devices failed a VOC test in August 2021. According to the FDA, Philips did not document any health hazard evaluation, risk analysis or design review following the failed test; thus the FDA requested Philips hire an independent lab to study the safety of the replacement foam.
Initially, it was reported that Philips was recalling 3 to 4 million devices; however, the FDA inspection report indicates that over 15 million devices have been recalled. The question now is whether the recall covered all of the breathing machines with toxic sound abatement foam
Philips announced the recall on June 14. The FDA inspected the Murrysville, PA Philips Respironics facility on 21 separate days from Aug 26 through Nov 9.
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The PE-PUR sound abatement foam in the recalled Philips CPAP, BiPAP and ventilator devices may cause cancer and serious respiratory problems.
Lawsuits are starting to be filed seeking compensation for injuries claiming Philips manufactured defective devices but didn’t warn the public of the risk or serious injuries.
If you or a loved one developed cancer, respiratory issues, or other serious health problems after using a defective Philips CPAP, BiPAP or other ventilator machine, contact the law offices of Nash & Franciskato at (877) 284-6600. The time to request your free, no-obligation case review is today. We will help you determine if your Philips breathing device is the cause of your health issues. We will review your case in a free and confidential consultation, with no risk or obligation to take legal action.
Call us today at (877) 284-6600. One of our experienced staff will speak with you personally and will provide you with a free, no-obligation review of your case.
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