Field Safety Notice Armstrong Medical Neonatal Breathing Circuits (ICN 2068)

Alert:

• Armstrong Medical has issued a Field Safety Notice following reports of the tubing, or connector attached to the tubing, disconnecting from the elbow within the neonatal breathing circuit of a number of devices.
• This could lead to delayed treatment to patient and/or oxygen desaturation, lung collapse (atelectasis), failure to maintain adequate pulmonary pressure support, or failure to provide means of alveolar gas exchange.
• Any of the above could result in patient injury including cardiac arrest leading to irreparable impairment or fatality.

Products Affected:

• The products affected are Aquavent Neo Heated Ventilator Circuits, NeoFlow Humidified Oxygen Systems and Aquavent Neo nCPAP Systems.
• 16 of the affected product codes are available from NHS Supply Chain via the eDirect route.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes.
• Please note only the batch numbers listed in the Field Safety Notice are affected.

Next Steps:              

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Complete and return the Field Safety Notice Response Form, found on page 12 of the notice, to quality@armstrongmedical.net to arrange return of any affected product.
• Please complete the Response Form even if you have no affected product.
• Please also contact your local NHS Supply Chain Customer Service Advisor with full details of all affected products in your possession to enable us to monitor any returns and manage your credit as appropriate.
• Where it is not practical to return devices, please follow the recommendations on page 2 of the Field Safety Notice.
• Armstrong Medical have confirmed that they are able to supply future orders with unaffected stock.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.