In June 2021, Royal Philips’ subsidiary, Philips Respironics, initiated a voluntary recall notification in the US/field safety notice in other countries for certain sleep and respiratory care products to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in certain CPAP, BiPAP and mechanical ventilator devices.
At the time the recall notification/field safety notice was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a reasonable worst-case scenario for the possible health risks. Following Philips’ public statements on the issue and possible risks to users in April 2021, and the announcement of the recall notification/field safety notice in June 2021, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation.
This led to an increase by approximately 20,500 MDRs filed by Philips Respironics to the FDA between April 2021 and April 2022. In the following 6 months through October 2022, Philips Respironics filed approximately 70,500 MDRs, and in November and December 2022 approximately 8,300 MDRs.The vast majority (93%) of the approximately 99,000 MDRs filed since April 2021 up to and including December 2022 are alleged technical malfunctions that do not involve serious injury. It is important to note that the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event, and that the cause of an event cannot typically be determined from this reporting system alone. Philips Respironics investigates all allegations of technical malfunction serious injury or death. Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in certain of these MDRs.
To date, more than 90% of the production required for the delivery of replacement devices to patients has been completed. In December 2022, Philips provided an update on the completed set of test results for first-generation DreamStation sleep therapy devices.
