National Patient Safety Alert: Philips Respironics V60 ventilator - unexpected shutdown (23 September 2020)

Summary

In March 2020 Philips Health Systems released an FSN concerning V60 ventilators. This FSN concerned a hardware fault in the device, which can result in an unexpected shutdown.

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 to the user. If a device fails in use and does not alarm, the patient will not be adequately ventilated and there is a potential risk of brain damage or death, depending on how long it takes clinicians to become aware of the situation and respond.

There has been a significant delay of replacement parts arriving in the United Kingdom, resulting in an increased risk of this failure occurring. The MHRA has decided to update the guidance issued in the Medical Device Alert published in June. The MHRA will continue to work with the manufacturer to improve the delivery time for replacement components.

Content

Actions required

Primary actions to be completed by 7 October 2020:

1. Identify and locate affected devices in your organisation.
2. Identify alternative ventilators available on site.
3. If no suitable alternative available, and capacity is an issue currently or expected imminently, follow protocol for resource shortage escalation set out by your local governance.
4. Train all relevant staff on alternative ventilators and ensure training records are up to date.
5. When actions 1–4 are complete, remove affected V60s from use and quarantine until repaired by the manufacturer.
6. Place the alternative devices into service in place of the affected V60s.
7. You may continue to use affected V60s 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. A backup form of ventilation must be available at all times.

Secondary action to be completed by 23 December 2020:

           8. Review procurement and stock policies to ensure you are not reliant on one manufacturer or model of ventilator.