Field Safety Notice Ambu® aView™ 2 Advance (ICN 2359)

Alert:

• Ambu has released a Field Safety Notice regarding for Ambu® aView™ 2 Advance.
• The supplier received information on two incidents where Ambu® aView™ 2 Advance caught fire when mounted on the VESA holder of the aCart™ Compact, due to the screws used entering the lithium-ion battery of the device.
• The fire hazard was a direct consequence of a battery short-circuit, which, in turn, was triggered by the use of excessively long screws to secure the device on the VESA holder.
• Customers are urged to be aware of the below Warning applicable to the Instructions for Use:
  • Use only M4 screws with the length of 14 – 16 mm when mounting Ambu aView 2 Advance on a VESA interface.

Products Affected:

• Three of the affected products have been available via NHS Supply Chain.
• Please note that FSM4451 is now deactivated and no longer available to order.
• FDB85857 and FDB85058 are currently available via our online catalogue.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice’s and share with all users of the affected products.
• Use only M4 screws with the length of 14 – 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the lithium-ion battery and result in a fire hazard and battery leakage which can cause severe burns, smoke inhalation and skin irritation. Using shorter screw lengths could result in unsecure device fastening.
• Please familiarise yourself with the information in the insert of Instructions for Use and keep the insert together with the Instructions for Use booklet.

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