Timeline Stories
January 11, 2021
Philips also conducted an internal biocompatibility risk assessment, which concluded that degraded foam presents a “significant biological risk to patients.”
December 10, 2020
Another Philips internal assessment indicated that there were risks posed to patients, determining “degraded PE-PUR foam is not considered biocompatible and presents significant biological risk to those patient populations who are exposed.”
July 2, 2020
An internal biological risk assessment conducted by Philips found that the “biological and toxicological risks from exposure to degraded PE-PUR foam are of concern.”
March 6, 2020
In response to customer’s request for written guidance on SoClean Ozone product, Philips wrote a letter stating that using SoClean product will not automatically void warranties though they hold the right to void warranties, declining to dissuade patients from using SoClean Ozone products.
January 31, 2020
According to the FDA, Philips management, including executives, “were aware of potential foam degradation issues concerning CPAPs, BiPAPs, and Trilogy ventilators” since at least this date, or earlier, but implemented “no further corrective actions until April 2021.” Additionally, the FDA found that the firm became aware of the issue and related field complaints in at least 2015 or earlier.
November 9, 2021
FDA investigators issued a 29-page 483 Report to Rodney Mell, Head of Quality at Philips Respironics, which is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
June 2019
In response, Philips finally initiated a formal CAPA, but according to the FDA this assessment “failed to evaluate all relevant data.” Nonetheless, the company's investigation ultimately concluded that the cause of degradation was “long-term exposure to environmental conditions of high temperature combined with high humidity.”
May 22, 2019
Philips’s internal testing reported the presence of formaldehyde in analyses of its DreamStation 1 devices, finding “tolerable limits of the Formaldehyde compound were exceeded during initial operation, as well as at the [redacted].” There is extensive research, including dozens of human epidemiological studies, showing an association between formaldehyde exposure and numerous forms of cancer.
April 2019
Philips received two complaints that “sound abatement foam ‘is degrading and entering the air path.’”
2019
The FDA concluded that Philips’s leadership had discussed foam degradation issues concerning CPAPs, BiPAPs, and Triology ventilators at management review meetings since at least 2019.