Special Alerts

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Philips Health Systems V60, V60 Plus and V680 ventilators [HKMD No.: 190021].

According to the MHRA, the manufacturer 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. 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

For further information, please visit https://www.gov.uk/drug-device-alerts/national-patient-safety-alert-philips-health-systems-v60-v60-plus-and-v680-ventilators-potential-unexpected-shutdown-leading-to-complete-loss-of-ventilation-natpsa-slash-2022-slash-002-slash-mhra

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 30 Mar 2022