Timeline Stories
2016
Philips conducted testing that revealed the PE-PUR foam used in many of its CPAP, BiPAP, and ventilator devices was susceptible to degradation, resulting in the conclusion that “polyester urethanes show bad resistance against high humidity in combination with high temperature.”
2014-2017
Philips received 110 complaints related to foam degradation but took no action to address the complaints.
2011
An adverse event report from the FDA Manufacturer and User Facility Device Experience (MAUDE) database shows that Philips investigated a patient report of “black dust” on her nose after using a Philips CPAP device.
2015
Philips received data from a variety of sources regarding degradation of the PE-PUR foam contained within the recalled devices, including complaints, test reports, information from suppliers, and information from another entity owned by Philips’s parent company. According to the FDA, Philips “failed to adequately evaluate this data and incorporate it into its CAPA (Corrective and Preventative Actions) system for further investigation and potential mitigation, as required by current good manufacturing practice requirements.”
November 2015
Philips asked foam supplier Polymer Technologies Inc. (Polytech) about the potential for PE-PUR foam degradation when exposed to “40C and high humidity.”
October 13, 2009
Philips Respironics issued a press release stating, “Royal Philips Electronics (NYSE: PHG, AEX: PHI) today introduced the next generation Philips Respironics Sleep Therapy System at Medtrade 2009, the leading conference and expo for the home medical equipment industry.” The Sleep Therapy System referred to in the press release was the System One 60, one of the Recalled Devices
June 2, 2009
Philips Respironics issued a press release stating, “Royal Philips Electronics (NYSE:PHG, AEX: PHI) today introduced the Trilogy100 portable at-home life-support ventilator.”
2009
Royal Philips took a lead role in launching and marketing several of the recalled devices with media promotion, and participation in medical device conferences.
2008
The earliest complaints discovered in a query by Food and Drug Administration (FDA) related to keywords: contaminants, particles, foam, debris, airway, particulate, airpath, and black. In total, the FDA found at least 222,000 complaints that could potentially be related to foam degradation that the company received from 2008 to 2017.