More than a dozen Philips Respironics machines which are designed to deliver pressurised air through a mask have been issued two field safety notices (FSN) to alert users that there could be a potential safety risk using the device.

The government issued the national patient safety alert in 2021 for Philips ventilator, CPAP and BiPAP devices. The alert states that there is a risk of potential harm to patients due to the inhalation of particles and the release of ‘volatile organic compounds.’
Concerns have also been raised regarding the degradation of foam in the machine, which could cause particles to be blown into the patient’s airway, causing irritation and an inflammatory response.
Meanwhile, there is also a worry that the release of volatile organic compounds including Dimethyl diazene and Phenol could cause serious harm to patients.
The alert states that although there is currently no definitive data showing long-term harm to patients, VOCs and degradation of the foam are associated with possible long-term effects such as genotoxicity; carcinogenic effects and neurotoxicity which could lead to various cancers.
According to the government, there have been no reported incidents of harm to people using these devices in the UK. But the US Food and Drug Administration warned of potential health risks that could be “life-threatening, cause permanent impairment and require medical intervention.”
Medicines and Healthcare products Regulatory Agency alerted NHS Trusts and health boards to take action in June 2021, to identify the affected devices, implement risk assessments and source alternative devices where clinically appropriate.
However, the alert suggests that patients should be advised not to stop using the devices unless a risk assessment has concluded that the risks outweigh the benefits.
If you have used one of the machines listed below, and believe you may have suffered from a long-term health issue as a result, feel free to get in touch with Oakwood Solicitors today.
All devices manufactured before 26 April 2021 are affected. This includes all device models and serial numbers listed below:
DreamStation ASV, DreamStation ST AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, Dreamstation Go, DreamStation SystemOne (Q-Series), Dorma 400, Dorma 500, REMstar SE Auto, OmniLab Advanced+
Trilogy 100, Trilogy 200, Garbin plus, Aeris, LifeVent, A-Series BiPAP Hybrid A30, A-Series BiPAP V30 Auto, A-Series BiPAP A40, A-Series BiPAP A30.
The machines are used as a non-invasive ventilation therapy to facilitate breathing. They are commonly given to patients with Obstructive Sleep Apnoea (OSA) and type 2 respiratory failure to help open the airways and prevent the throat from collapsing while they sleep.
BPAP machines use pressure to push air into the lungs to improve the level of oxygen in the blood, as well as decrease carbon dioxide. Meanwhile, CPAP machines deliver a stream of oxygenated air into the airways through a mask and tube to keep your airways open while you sleep.
Hospital negligence – Oakwood Solicitors
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Jade Glover is a Solicitor in the Medical Negligence team. She has worked for the company for over 9 years and completed her training during that time. She has specialised in Personal Injury clai…
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