Medical Device Field Safety Notice (outside of U.S.)
Philips Respironics Sleep and Respiratory Care devices
FSN 2021-05-A & FSN 2021-06-A
Below is an update on the status of our repair and replacement program for impacted CPAP, BiPAP and mechanical ventilator devices as of April 30, 2023. In addition to the number of replacement devices delivered, we also provide an overview of the number of devices that will be financially compensated and the number of devices that can no longer be traced by home care providers.
955 997
Number of repair kits and replacement devices produced for Western Europe1
15 561
Number of remediated devices shipped to customers in Ireland
3 487
Financial compensation2 of devices to the home care providers
0
Untraceable devices3
1. A number of older System One sleep apnea devices are no longer manufactured and sold by Philips. In many cases, these devices are older than five years. In consultation with the home care providers, Philips has agreed on a solution for these patients. For part of the used devices, home care providers receive alternative or repaired devices. In addition, Philips offers financial compensation for some of these System One devices so that home care providers can purchase another device for the patient.
2. The home care providers have registered a number of devices that are no longer in use or can no longer be traced. The home care providers have made efforts to trace all devices and patients. We assume that devices that are no longer traceable are no longer in use.
You are about to visit a Philips global content page
Continue
Patient safety is our top priority. We are committed to completing the remediation of all registered devices and have substantially increased the production of replacement devices.
With devices ready for patients, we are working with customers and clinicians to help get these devices to those who need them.
It is important that patients feel confident using their devices. Since the field safety notice, we’ve carried out a test and research program to learn more about the polyester-based polyurethane (PE-PUR) sound abatement foam, working with independent laboratories and third party experts and physicians. The latest results of the testing and analysis we have done over the past 18 months can be found here.
We know there is still more to be done. As we continue to work through the voluntary field safety notice, we assure you that we are fully committed to supporting all patients and will continue to partner with clinicians and business customers to complete remediation efforts.
May 2023 update on completed testing for home sleep therapy devices shows no appreciable harm to patients
The tests, conducted together with five independent, certified testing laboratories and assessed by third- party qualified experts and Philips Respironics, as well as an external panel of experts, have now been completed and risk assessments evaluated for all home sleep therapy devices.
You are about to visit a Philips global content page
Continue
Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used.
Not yet registered?
December 21, 2022 - Update on completed testing for first-generation DreamStation devices Based on the extensive testing and analysis that we have done over the past 18 months – working with five independent certified laboratories, as well as third party experts and physicians - we now have a complete set of results** for the first-generation DreamStation devices.
Jan Kimpen, Chief Medical Officer, discusses what the test results mean for healthcare providers and their patients
Jan Bennik, Head of Test and Research Program, explains the details behind the testing results
** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions. Healthcare providers, patients, and other stakeholders should use the complete update, including information on the limitations of the testing, for any informed decision making and should not solely rely on the overview presented here. Philips Respironics’ guidance for healthcare providers and patients remains unchanged. Philips Respironics will continue with the remediation program.
November 23, 2022 - Philips provides an update related to Trilogy 100/200 repairs These problems do not affect any of the CPAP or BiPAP sleep apnea devices that have been remediated.
Philips Respironics has detected two problems with corrected Trilogy 100/200 ventilators following a limited number of complaints from the US and Japan.
July 25, 2022 - Summary of a systematic literature review of Positive Airway Pressure device use and cancer risk
Philips Respironics engaged external scientific experts to perform an independent systematic literature review of epidemiological studies to evaluate whether use of Continuous or Bilevel Positive Airway Pressure (PAP) devices increases the risk of cancer in obstructive sleep apnea (OSA) patients.
Based on 13 epidemiological studies identified from the systematic literature review, no association has been established between use of PAP devices, including Philips Respironics PAP devices, and risk of cancer in patients with OSA. Two rigorous independent studies showed no statistical difference in cancer risk between OSA patients who used Philips Respironics PAP devices versus other brands of PAP devices. Eleven other epidemiological studies provided little additional insight into this question, but their results generally suggested no excess risk of cancer associated with PAP use for OSA.
June 28, 2022 - Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program.
Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice
Technical Project Manager Jan Bennik speaks about the test and research program
May 24, 2022 - An analysis was published online in the European Respiratory Journal that concluded that sustained and adherent CPAP therapy of OSA using Philips Respironics devices, compared with other manufacturers’ devices, was not associated with an increased risk of cancer after a median follow-up time of 7.2 years.
The analysis and conclusion were based on data from a large multicenter cohort study involving 4,447 OSA patients on CPAP devices between 2007 and 2018, including 1,648 Philips Respironics CPAP users. Philips Respironics was not involved in the study or the analysis.
Dec 15, 2021 - A completely independent Canadian study was published in the American Journal of Respiratory and Critical Care Medicine.
This study did not show a higher risk in patients with CPAP compared to patients using a device from another manufacturer.
Questions and answers
DreamStation ASV
Also known as DreamStation BiPAP autoSV
DreamStation ST, AVAPS
Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T
SystemOne ASV4
Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced
C Series S/T, AVAPS
Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series)
OmniLab Advanced Plus
In-Lab Titration Device
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
A-Series BiPAP Hybrid A30
Also known as BiPAP Hybrid A30Ventilator (A-Series)
(not marketed in US)
A-Series BiPAP V30 Auto Ventilator
Also known as BiPAP V30 Auto Ventilator (A-Series)
Continuous Ventilator, Non-life Supporting
A-Series BiPAP A40
Also known as BiPAP A40 Ventilator (A-Series)
(not marketed in US)
A-Series BiPAP A30
Also known as BiPAP A30 Ventilator (A-Series)
(not marketed in US)
If your device is affected...
What products are not affected and why?
Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design.
