Statement on Field Safety Notices issued by Philips Respironics on Sleep and Respiratory Care Devices

The HSE has recently been made aware of a field safety notice issued by the manufacturer Philips relating to a number of ventilation devices used for sleep and respiratory care. (list outlined below)

These devices are used both in hospitals and in community care settings.

The HSE is working with the HPRA and our hospital and community services to further assess this issue and the potential impact on patients in Ireland.

As a precautionary measure the HSE has commenced the process of identifying the locations of where these devices may be in use. This includes public hospitals, residential care settings and patients own homes. The HSE has been in contact with other relevant care providers to alert them to the field safety notice including Nursing Homes Ireland, Contracted Care Providers and Private Hospitals. 

Patients who are currently using one of the affected devices may shortly receive communications from the company that supplied their device and it is important that patients pay particular attention to instructions given.  

These companies include:

Air Liquide Tel 1800 740202 (option 3)                                             

Direct Medical Tel 0906490190

BOC Tel 1800 220202

Based on the current information supplied by Philips, the HSE recommends that all patients and device users continue to use their device as prescribed until a replacement device is supplied or the device repaired. 

The HSE awaits further information from the manufacturer before our clinical experts and health specialists can provide further advice to patients. In the interim patients are advised to continue using their device as prescribed by their doctor. If any patient or carer has concerns regarding the device they are using they are advised to check the device serial number and to contact the company who supplied their device for further information. Patients should contact their doctor if they have any further concerns.

Patients can obtain further information or support from Philips at 1800 851 241 or https://www.philips.ie/healthcare/e/sleep/communications/src-update.

The HSE will continue to work with the HPRA to make additional information and guidance available. 


Ends

List of Devices under the Field Safety Notice Philips Respironics: 

List of Devices under the FSN

All Devices manufactured before 26 April 2021, All serial numbers :

E30 (Emergency Use Authorization), 

DreamStation ASV, 

DreamStation ST, AVAPS 

SystemOne ASV4

C-Series ASV 

C-Series S/T and AVAPS 

OmniLab Advanced+ 

SystemOne (Q-Series) 

DreamStation 

DreamStation Go 

Dorma 400 

Dorma 500 

REMstar SE Auto

Trilogy 100 

Trilogy 200 

Garbin Plus, 

Aeris, 

LifeVent 

A-Series BiPAP Hybrid A30 (not marketed in US) 

A-Series BiPAP V30 Auto

BiPAP A40 

Information on Distributor contact numbers

If you need any further information or support concerning this issue, please contact the support hotline or visit the website: 

 1800 851 241 

https://www.philips.ie/healthcare/e/sleep/communications/src-update

FAQ

What type of devices and how many?

They are ventilation devices used for sleep and respiratory care. These devices are used both in hospitals and in community care settings.

The Manufacturer estimates that 23,000 devices have been distributed to Ireland since 2007. Many of the devices may now not be in use. The devices may have been used in both public and private hospitals and residential care settings and patients own homes. The HSE estimates that approximately 10,000 products have been distributed through the contracted providers in Ireland. 

What is the risk to patients? 

According to the manufacturer, the polyester-based polyurethane foam used in their devices may degrade into particles and volatile gas products, which the user may inhale. This may result in potential health risks for the user, including local airway irritation. Some of the volatile chemicals have been shown to be a possible carcinogenic risk. Further information on the potential risks of degraded foam exposure are listed on the manufacturer’s website. The degradation may be accelerated by unapproved cleaning methods (e.g. ozone). Information on the toxicity and clinical relevance of particulate matter and volatile gases over the short or long term is currently not known.  

To date no evidence of acute life-threatening incidents with patients have been reported. There have been a small number of adverse event reports, describing features such as cough, headache and sinus infection in users.

If I have any symptoms what should I do ?

Patients who are worried about symptoms and are using one of the devices should speak to their doctor for advice and guidance. Your doctor will discuss with you the risk due to physical or chemical injuries on the one hand, against the acute and chronic risk of cessation of treatment of sleep apnoea or respiratory failure on the other.  Based on current information supplied by Philips, the HSE recommends that all patients and device users continue to use their device as prescribed until a replacement device is supplied or the device repaired.

It is particularly important that for patients with severe breathing difficulties, excessive daytime sleepiness, ventilator failure using non-invasive or invasive ventilation, significant pulmonary, cardiovascular or neurological comorbidities, or accident risk at their workplace or when driving, therapy should not be stopped or altered until a comparable alternative is available.​

What do I need to do if I have am using one of these devices?

You should contact the contracted company that supplied the device to you to seek advice and guidance and follow the advice. You should also check the serial number of your device and contact Philips and register the device on their online portal as advised. Patients can obtain further information or support from Philips at 1800 851 241 or https://www.philips.ie/healthcare/e/sleep/communications/src-update.

 

Last updated on: 24 / 06 / 2021