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Originator: National Patient Safety Alert - MHRA

Issue date: Originally issued on 29-Mar-2022 11:36:31. This version was issued on 29-Mar-2022 11:36:31

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
  • Special Health Authorities
  • Territorial CMOs in Northern Ireland, Scotland & Wales

Action category: Action

Title: UPDATED 25/05/22: Philips Health Systems V60, V60 Plus and V680 ventilators – potential unexpected shutdown leading to complete loss of ventilation

Broadcast content:

***Update 2: 25/05/2022: The deadline for this National Patient Safety Alert has been updated to 12 July 2022. This is following feedback that owing to high demand for replacement devices it will not be possible to complete actions by the previous deadline of 31 May 2022.***


***Update 1: 03/05/2022: The manufacturer has released a field safety notice (FSN) on this issue, published on the MHRA website 03/05/22. The MHRA would like to remind users that the advice in this National Patient Safety Alert supersedes the advice given by the manufacturer in their FSN. Failure to take the required actions detailed may lead to regulatory action. The MHRA has reconfirmed this advice as no longterm solution to this device problem has been implemented to date, therefore it is still felt that there is a significant risk to patients.***


In March 2022 Philips Health Systems informed the MHRA of an important safety issue due to potential unexpected shutdowns of all of their V60 and V60 Plus non-invasive ventilators.  All V680 invasive ventilators used in critical care settings are also affected.

V60 and V60 Plus devices are designed for in-hospital use. They can be used to provide average volume-assured pressure support (AVAPS), pressure-controlled ventilation (PCV), continuous positive airway pressure (CPAP), and positive pressure ventilation (PPV) treatment to patients in critical care and high-dependency unit (HDU) settings.

The safety concern identified relates to a number of electrical faults in the devices, which can result in an unexpected shutdown, leading to loss of ventilation.

There are two ways in which this shutdown can occur: The first will sound a warning to alert the user that the machine is shutting down. This will let the user know they need to switch to an alternative source of ventilation. There is a risk that the patient will be unventilated while this second source of ventilation is prepared.

The second failure mode will cause the device to shut down with no warning alarm. If a ventilator fails in use and does not alarm, the patient will be unventilated until the clinician becomes aware and responds.

If unnoticed by healthcare professionals, ventilation failure can have a severe health impact on patients.  This can include hypoxia, which can result in long-term cognitive impairment to the patient.  There is also a risk of death if a patient is without ventilation for a sustained period of time

Philips has no permanent solution to correct this issue and as such we are issuing this alert to help hospitals manage the risk.

Note: This is a different alert to the one previously published on 23/09/2020 by the MHRA for a similar range of devices.

This alert should be acted on immediately.



Additional information: This alert is not relevant to Primary Care

Alert reference: NatPSA/2022/002/MHRA

Action underway deadline: 27-May-2022

Action complete deadline: 12-Jul-2022

Attachments:

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency