If unnoticed by healthcare professionals, ventilation failure can have a severe health impact on patients. If a ventilator fails in use and does not alarm, the patient will be unventilated until the clinician becomes aware and responds. The second failure mode will cause the device to shut down with no warning alarm. There is a risk that the patient will be unventilated while this second source of ventilation is prepared. This will let the user know they need to switch to an alternative source 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. 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. 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. V60 and V60 Plus devices are designed for in-hospital use. All V680 invasive ventilators used in critical care settings are also affected. If you have experienced any incidents related to this issue the MHRA would encourage you to report this via the Yellow Card Reporting scheme.įor any enquiries please contact: 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. 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. 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. However, providers should register with Philips for the corrective action prescribed in the FSN.ĭevices 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. ![]() Providers that have completed the required actions detailed in the MHRA alert are not required to take any further action at this time. Providers that are in the process of completing the actions detailed in the alert should continue to do so. ![]() The advice in the National Patient Safety Alert has not been altered. 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. 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 are providing an update on the situation surrounding the Philips V60, V60+ and V680 ventilators unexpected shutdown issue. MHRA Update V60, V60+ and V680 ventilators unexpected shutdown issue 29 July 2022
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