Summary
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.
Content
All actions to be completed by 31 May 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 1–3 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 1–3 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).
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