Medical Device Field Safety Notice (outside of U.S.)


Philips Respironics Sleep and Respiratory Care devices

 

FSN 2021-05-A & FSN 2021-06-A

Information for business customers

 

We are committed to partnering with you to support all affected patients.


While we've made progress with CPAP and BiPAP devices,  we remain on a separate remediation timeline for ventilation devices. Please visit our ventilation news and updates page for the latest information.

Support at every step of the way

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Get the latest information and resources

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Learn more about the remediation process

While we work to provide patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process and the tools and resources available to support your patients.

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Understand the steps we take to ensure the safety of your replacement CPAP or BiPAP device

 

While we work to provide replacement devices as quickly as possible, we want to share the steps we are taking to ensure your First Generation DreamStation replacement device is safe to use so you can be confident in your new device.

Find out all the details and watch an explanatory video here.

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Summary of the latest results and conclusions of the complete programme of tests and research for your patients

 

Philips Respironics has additional conclusions for the first-generation DreamStation, System One and DreamStation Go products. We are committed to your safety and want you to be confident in using your device, but understand that testing can be very technical and therefore challenging to understand. So, let’s break down the findings from independent, certified testing laboratories and qualified third-party experts including toxicologists and medical experts. Download the infographic.

DreamStation 2

Your patients may receive a DreamStation 2 as a replacement for their affected CPAP device.

 

The Philips Learning connection hosts educational modules that provide overviews of the DreamStation 2 and DreamStation 2 Advanced.

Questions and answers

The following products listed are affected by the field safety notice:

CPAP and BiLevel PAP Devices

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

E30 Emergency Use Authorization

E30

(Emergency Use Authorisation)

Continuous Ventilator, Non-life Supporting

DreamStation ASV

DreamStation ASV

Also known as ​DreamStation BiPAP autoSV​

DreamStation ST, AVAPS

DreamStation ST, AVAPS

Also known as​ DreamStation BiPAP AVAPS, ​DreamStation BiPAP S/T

SystemOne ASV4

SystemOne ASV4

Also known as​ System One BiPAP autoSV, ​System One BiPAP autoSV Advanced​

C Series ST, AVAPS

C Series S/T, AVAPS

Also known as​ System One BiPAP AVAPS (C-Series), ​System One BiPAP S/T (C-Series)​​​

OmniLab Advanced Plus(sleep lab) CPAP

OmniLab Advanced Plus

In-Lab Titration Device

Non-continuous Ventilator

50 Series CPAP, ASV

System One 50 series

CPAPs, Auto CPAP, BiPAPs​

60 Series CPAP, ASV

System One 60 series

CPAPs, Auto CPAP, BiPAPs​

DreamStation CPAP

DreamStation CPAP, Auto CPAP, BiPAP

DreamStation Go

DreamStation GO CPAP, APAP, Auto CPAP

Dorma 400, 500

Dorma 400, 500 ​CPAP, Auto CPAP

(not marketed in US)​

Mechanical Ventilators

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator

Trilogy 100

Trilogy 100 Ventilator

Trilogy 200

Trilogy 200 Ventilator

Garbin Plus, Aeris, LifeVent Ventilator

Garbin Plus, Aeris, LifeVent Ventilator

(not marketed in US)

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A-Series BiPAP Hybrid A30

A-Series BiPAP Hybrid A30

Also known as ​BiPAP Hybrid A30​Ventilator​ (A-Series)​
(not marketed in US)

A-Series BiPAP V30 Auto Ventilator

A-Series BiPAP V30 Auto Ventilator

Also known as​ BiPAP V30 Auto​ Ventilator ​(A-Series)

Continuous Ventilator, Non-life Supporting

A-Series BiPAP A40

A-Series BiPAP A40

Also known as ​BiPAP A40​ Ventilator ​(A-Series)​
(not marketed in US)​​

A-Series BiPAP A30

A-Series BiPAP A30

Also known as ​BiPAP A30​ Ventilator​ (A-Series)​
(not marketed in US)​​

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.

  • Trilogy Evo

  • M-Series

  • Trilogy Evo OBM

  • Trilogy EV300

  • Trilogy 202

  • A-Series Pro and EFL

  • DreamStation 2

  • Omnilab (original based on Harmony 2)

  • Dorma 100, Dorma 200, & REMStar SE

  • V60 Ventilator

  • V60 Plus Ventilator

  • V680 Ventilator

  • All oxygen concentrators, respiratory drug delivery products, airway clearance products.

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