Amsterdam, the Netherlands – In June 2021, Royal Philips’ (NYSE: PHG, AEX: PHIA) 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 a steep increase by more than 20,000 Medical Device Reports (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 an additional approximately 70,000 MDRs. The vast majority (93%) of the approximately 90,000 MDRs filed since April 2021 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.