Philips Health Systems Ventilators Safety Hazard Alert

Philips Health Systems ventilators safety hazard alert. This alert concerns V60 and V60 Plus non-invasive ventilators. The official warning from the Medicines and Healthcare products Regulatory Agency (MHRA) is published on March 29, 2022.

Philips Health Systems has found a serious safety concern related to the potential for all of their V60 and V60 Plus non-invasive ventilators to shut down unexpectedly. Invasive ventilators with the V680 model number are also affected in critical care situations.

THIS IS A NATIONAL PATIENT SAFETY ALERT FROM THE BRITISH HEALTHCARE REGULATOR

All hospital trusts and other healthcare providers who use the impacted ventilators should take action as soon as possible. This is a complex and life-threatening National Patient Safety Alert. An executive leader should be in charge of implementation, care and heads of procurement.  

Philips Health Systems Ventilators safety hazard alert. Philips Health Systems has found a serious safety concern in V60, V60 plus & V680
Philips Health Systems has found a serious safety concern | Photo source: Philips Netherlands

Explanation of Identified Safety Issue

In March 2022, Philips Health Systems notified the MHRA of a serious safety concern over the potential for all of their V60 and V60 Plus non-invasive ventilators to shut down unexpectedly. Invasive ventilators with the V680 model number are also affected in critical care situations.

The V60 and V60 Plus are intended for usage in hospitals. They can be used to treat patients in critical care and high-dependency units (HDUs) with average volume-assured pressure support (AVAPS), pressure-controlled ventilation (PCV), continuous positive airway pressure (CPAP), and positive pressure ventilation (PPV).

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.This shutdown can take place in two ways: 

  • The first will emit a warning tone to inform the user that the machine is about to shut down. This will alert the user that they need to change their ventilation source. While this second source of ventilation is being prepared, the patient may become unventilated.
  • The device will shut down without notice in the second failure condition. The patient will be unventilated until the clinician becomes aware and responds if a ventilator fails in use and does not alarm.

Ventilation failure can have a serious health impact on patients if it goes unreported by healthcare workers. Hypoxia is one example, which might cause long-term cognitive impairment in the patient. If a patient is without ventilation for an extended period of time, there is a risk of death.

Because Philips does not have a permanent solution to this problem, the MHRA issues this alert to assist hospitals in managing the risk.

Note: This is not the same notice that the MHRA issued on September 23, 2020, for a similar set of devices. This alert should be followed up on right away.

Actions Required

All Actions to be Completed by 31 May 2022

  • Urgently identify and locate affected devices in your organization.
  • Identify alternative ventilators available on site. (a) If no alternatives are available, use local procurement procedures to acquire suitable alternative devices. (b) If no suitable alternative is available, and capacity is an issue currently (or expected imminently), additional devices are available for NHS organizations. Details for how to access these devices can be found in the ‘Additional information’ section of this alert.
  • Train all relevant staff on alternative ventilators and ensure training records are up to date.
  • If continued use of the device is required while actions 1–3 are implemented, extra patient monitoring should be enacted as detailed in the ‘Additional information’ section. A backup form of ventilation must be available at all times
  • When actions 1–3 are complete, remove affected ventilators from use and quarantine.
  • Place the alternative devices into service in place of the affected ventilators
  • You may continue to use affected ventilators if there is a risk of severe patient harm due to lack of ventilator availability. A thorough risk assessment must be completed, and additional monitoring must be used (see action 4).

Additional Information for the Philips Health Systems Ventilators Safety Hazard Alert

Information on Adverse Incidents

Philips has received five reports of unexpected shutdowns in the UK linked to this issue since 2018. All of these occurrences were preceded by relevant alarms. To yet, no patient injury has been documented in the United Kingdom.

There have been 340 reports of similar failures all around the world. There have been a lot of major injuries as well as several fatalities as a result of this. In the United Kingdom, none of the cases involving patient death or harm have occurred.

Ordering of Replacement Devices if Required

The DHSC National COVID ICU Equipment Reserve provides free alternate ventilators to NHS organizations in the United Kingdom. A limited number of Lowenstein Medical Prisma VENT50-C devices will be made available to ease the transition away from the affected Phillips devices in cases where there is an immediate clinical necessity.

Organizations in the NHS in England can order this equipment directly via their regional EPRR leads on the NHS Foundry system.

Devolved Administrations can order equipment by emailing the DHSC Medical Technology Directorate Operations team at medtech.operations@dhsc.gov.uk.

Please contact medtech.operations@dhsc.gov.uk if you have any questions or would like to request a full list of available devices.

Devolved Administrations Additional Contact Points for Supply Issues

  • Scotland – Health Boards in Scotland should contact National Procurement to discuss COVID-19 pandemic ventilator supply (if required). National Procurement contact details are: Kate Henderson, kate.henderson@nhs.scot, tel: 0781 353 1487 or Josh Foggo, josh.foggo@nhs.scot, tel: 07855 060 653.
  • Wales – Please contact haz-aic@gov.wales for guidance.
  • Northern Ireland – please contact niaic@health-ni.gov.uk.

Risk Assessment and Additional Patient Monitoring Requirements

Philips Health Systems ventilators safety hazard alert:

Philips Health Systems Ventilators safety hazard alert. Official MHRA alert in an overview.
Official MHRA alert in an overview | source: Patient Safety Alert

If any of the impacted devices must be used until suitable substitutes can be found, a thorough risk assessment must be conducted and recorded before the patient starts breathing.Patients who need to use these ventilators should be placed in a ward where they can be observed by healthcare professionals. If the patient is in a respiratory or acute medical ward, consider whether they should be moved to a critical care unit. At all times, a backup source of ventilation must be accessible.

When possible and appropriate, independent capnography (CO2) monitoring should be used. This monitoring should have alarm limits that are appropriate for the patient. Capnography is used to ensure that the patient is breathing and that airflow is passing through the machine. It should not be used to monitor CO2 levels in place of blood collection. Capnography monitoring should be taught to all staff who care for the patient.

At all times, the patient’s physiological status should be monitored appropriately. This comprises non-invasive blood pressure, electrocardiogram (ECG), and blood oxygen saturation levels (SpO2). All measurement alarm limits should be set appropriately for the patient. All alarms should be attended to as quickly as possible.

Stakeholder Engagement

An incident management team was consulted on the actions detailed in this alert. This team consisted of members of the Department of Health and Social Care, NHS England and NHS Improvement, and representatives from the Scottish, Welsh, and Northern Ireland Governments.

Report any suspected or actual adverse incidents involving these devices through your healthcare institution’s local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

For any enquiries about this alert contact: info@mhra.gov.uk

Sources, links, and downloads for additional information: