Field Safety Notice Fisher & Paykel Healthcare AirvoTM 2 and myAirvoTM 2 Disinfection Kit User Manual Update (ICN 3127)

NHSSC: 78

Alert:

• Fisher & Paykel Healthcare have issued a Field Safety Notice informing of an update to the Disinfection Kit User Manual for Airvo 2 and myAirvo 2 devices.
• The Airvo 2 and myAirvo 2 have an audible alert that sounds for at least 120 seconds when the unit is unintentionally disconnected from a power source.
• This update has been made due to reports of the audible alert sounding for less than 120 seconds, which may delay user awareness to reconnect power.
• The supplier has updated the Disinfection Kit User Manual to include a regular test of this alert, to be carried out in between patient uses:
  • 7a: Preform ‘Power-Out Alarm’ test (Airvo and myAirvo only).

Products Affected:

• The two products affected are available from NHS Supply Chain:

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Fisher & Paykel advise customers may continue to use Airvo 2 and myAirvo 2 devices with appropriate patient monitoring as per the User Manual. When using the device, all instructions, including warnings and cautions in the User Manual must be followed, particularly those in Section 1.
• Complete the Response Form and return to: FieldActionUKIE@fphcare.co.uk

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care Team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.