Medicines Healthcare Products Regulatory Agency
Date of issue: 03 May 2022
Reference No: NatPSA/2022/002/MHRA
This alert is for action by: All hospital trusts and other healthcare providers using the affected ventilators.
This is a safety critical and complex National Patient Safety Alert. Implementation should be coordinated by an executive leader (or equivalent role in organisations without executive boards). Supported by their clinical lead for critical care and heads of procurement.
Explanation of identified safety issue
MHRA Update V60, V60+ and V680 ventilators unexpected shutdown issue 29 July 2022
The MHRA are providing an update on the situation surrounding the Philips V60, V60+ and V680 ventilators unexpected shutdown issue.
Philips Field Safety Notice
Philips published a Field Safety Notice (FSN) on 25 July 2022 containing a corrective action to address the lack of alarm accompanying the loss of ventilator function.
The MHRA would like to highlight that the risk of unexpected loss of ventilator function remains with these devices, and therefore there is still a risk of severe patient harm.
MHRA advice to providers
The advice in the National Patient Safety Alert has not been altered. Providers that are in the process of completing the actions detailed in the alert should continue to do so.
Providers that have completed the required actions detailed in the MHRA alert are not required to take any further action at this time. However, providers should register with Philips for the corrective action prescribed in the FSN.
Devices that have been removed from service should not be returned to use, even if they have received the corrective action detailed in the Philips FSN. If there is a risk of patient harm due to capacity issues then an appropriate risk assessment of the ventilators should be conducted and recorded and actions taken in line with the National Patient Safety Alert.
The MHRA continues to work with Philips to ensure that the alarms on the affected devices will sound in case of loss of ventilation, however Philips are yet to establish a timeline for this implementation.
Contacting the MHRA
If you have experienced any incidents related to this issue the MHRA would encourage you to report this via the Yellow Card Reporting scheme.
For any enquiries please contact: info@mhra.gov.uk.
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 September 2020 by the MHRA for a similar range of devices.
This alert should be acted on immediately.
Actions required
All actions to be completed by 12 July 2022
1.Urgently identify and locate affected devices in your organisation.
2.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 organisations. Details for how to access these devices can be found in the Additional information section of this alert.
3.Train all relevant staff on alternative ventilators and ensure training records are up to date.
4.If continued use of the device is required while actions 13 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
5. When actions 13 are complete, remove affected ventilators from use and quarantine.
6. Place the alternative devices into service in place of the affected ventilators
7. 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
Updated information published 25 July 2022
Manufacturers Field Safety Notice
The manufacturer originally published a Field Safety Notice (FSN) on this issue, 3 May 2022. This remains on the MHRA website and is different from the FSN published 25 July 2022. 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 solution to the risk of loss of function has been implemented to date or has been scheduled by the manufacturer, therefore it is still considered that there is a significant risk to patients.
Information on adverse incidents
Since 2018 the manufacturer has received 5 reports of unexpected shutdowns occurring in the UK related to this issue. All of these incidents were accompanied by the appropriate alarms. There has been no patient harm reported in the UK to date.
Worldwide, there have been 340 reports of these failures occurring. This has included a number of serious injuries and some fatalities. None of the incidents involving patient death or injury have occurred in the UK.
Ordering of replacement devices if required
NHS organisations in the UK can request alternate ventilators free of charge from the DHSC National COVID ICU Equipment Reserve. This includes a limited quantity of Lowenstein Medical Prisma VENT50-C devices, which will be made available to facilitate withdrawal from use of the affected Phillips devices when there is an urgent clinical need.
Organisations 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.