The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning HeartStart FR3 Automated External Defibrillators (AEDs), manufactured by Philips Health Systems [Model Numbers: 861388, 861389; Serial Numbers: begin with C16J, C16K, C17A, or C17B].

The manufacturer has identified that the affected products may not meet their IPx5 water ingress specification due to an improper sealing of the top and bottom enclosures. According to the manufacturer, the affected device subjected to strong water streams for an excessive amount of time may suffer from water intrusion into the device, potentially resulting in a failure of the AED. To date, the manufacturer has not received any reports of water ingress affecting the performance of these devices

• The customers are advised to take the following actions:
  • To identify impacted devices by inspecting the serial numbers.
  • The affected users may continue to use devices until a replacement FR3 AED is provided.
  • As a precaution, they should prevent the use of a pressurized water stream on the device for purposes such as cleaning.
• The manufacturer's representative will contacted the customers to replace the affected products.

According to the local supplier, the affected products are distributed in Hong Kong.

For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01393-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 24 Oct 2018