In March 2020 Philips Health Systems released an FSN concerning a number of V60 ventilators. This FSN concerned a hardware fault in the device, which can result in an unexpected shutdown.
There are 2 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. MHRA has decided to update the guidance issued in the Medical Device Alert published in June.
MHRA will continue to work with the manufacturer to improve the delivery time for replacement components.
See additional information in the attached alert for the complete list of affected device serial numbers.