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Originator: National Patient Safety Alert - MHRA

Issue date: Originally issued on 23-Jun-2021 15:50:44. This version was issued on 23-Jun-2021 15:50:44

This alert has been issued to:
  • Care Trusts
  • Mental Health Trusts
  • Specialists Trusts
  • Learning Disabilities Trusts
  • Mental Health & Social Care Trusts
  • Ambulance Trusts
  • Mental Health & Learning Disabilities Trusts
  • Acute Trusts
  • Community Trusts

  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • Social Care Providers (registered with CAS)
  • Special Health Authorities
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • Director of Public Health
  • GP - Locum
  • NHS 111 and Out of hours providers
  • GP Practices
  • Primary Care Networks
  • GP Practices 1

Action category: Action

Title: Philips ventilator, CPAP and BiPAP devices: Potential for patient harm due to inhalation of particles and volatile organic compounds

Broadcast content:

***The action complete deadline for this alert was originally set at 17 December 2021 and has now been extended to 21 February 2022. The attachment has been updated to reflect the new deadline date.***

Philips have issued 2 FSNs about selected ventilators and CPAP and BiPAP devices. These devices are primarily used in patients with Obstructive Sleep Apnoea (OSA) and type 2 respiratory failure.

There is a risk of patient harm from degradation of the sound abatement foam found in these devices.  Reports of incidents related to this issue are rare, and no incidents of harm have been reported in the UK.

There is currently no definitive data showing long-term harm to patients, but VOCs and degradation of the foam are associated with possible long-term effects such as: genotoxicity; mutagenic and carcinogenic effects; hepatotoxicity; nephrotoxicity; neurotoxicity.

Additional information: We are sending this alert to GP Practices for awareness in case of queries you may receive directly from patients. There is no specific action for Practices to take.

Alert reference: NatPSA/2021/005/MHRA

Action underway deadline: 23-Dec-2021

Action complete deadline: 21-Feb-2022


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency