Field Safety Notice Dräger VentStar Resus Neo and VentStar Resuscitaire (ICN 3478)

NHSSC: 62

Alert:

• Dräger has issued a Field Safety Notice following reports of obvious cracks in the hose of the VentStar Resus Neo and VentStar Resuscitaire being detected by the users prior to use.
• Where a cracked hose is used, the hose could fall off or leakage may occur. Depending on the leak, ventilation will be restricted and therapy could be delayed potentially resulting in desaturation, hypoxia or patient death.
• Dräger advises it has received no reports of any negative effects on the health of the affected patients. However, this cannot be completely ruled out if such cracks remain undetected.

Products Affected:

• Two products are affected.
• The two products affected are available via NHS Supply Chain:

• Dräger confirmed its analyses revealed the affected hoses developed cracks shortly after the manufacturing and assembly process. Stress tests on “flawless” hoses show that they can safely be used as normal.
• Due to the difficulty in identifying the specific batch numbers affected, Dräger took the decision to include, in the scope of this notice, all shipments made in the last three years (shelf life).
• Dräger advise unaffected products are available now on the standard 5-day lead time.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Carefully inspect the hoses for damages prior to use according to the product’s Instructions for Use (IFU).
• Discard products that show cracks (See Fig.1 page 2 of the FSN) or have a detached hose (Fig. 2). You do not need to return them to Dräger.
• Complete the Customer Reply Card to confirm you have received this information and that where appropriate all affected parts have been discarded and email it to: SafetyNoticeUK.C.GB@Draeger.com.
• On receipt of the completed card, Dräger will arrange to issue replacement devices free of charge.
• Please also contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products, including national product code and quantity disposed requiring replacement. Your Customer Services Advisor will give you a unique CMS log number and help if needed.
• Please note Dräger advises it has already contacted all potentially affected customers.

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