| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00229-1 |
| Product Name/Description |
HeartStart FRx, HeartStart Home, and Heartstart OnSite
All AEDs manufactured between 2002 to 2013 (660,000 units )
Possible R92 Resistor Failure
ARTG Number: 92346 (Philips Electronics Australia Ltd Defibrillator - Non-rechargeable public automated external defibrillator) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Philips has become aware of a specific electronic failure with one of the resistors. Virtually all of these resistor-related failures were detected through the devices’ automatic self-testing, alerting the user by issuing audible chirps. However, in rare instances, self-tests might not identify a problem and the device might not deliver a shock when needed. To date, Philips is aware of 13 instances in which this component failed during treatment, out of more than 45,000 uses in which shock therapy was delivered.
In all these instances, the device delivered at least one shock before failure. Among the cases for which the patient outcome is known, in overseas jurisdictions, 5 patients died and 2 patients were successfully resuscitated and survived.
The in-use reliability of these AEDs is greater than 99.9% when the AED determines a cardiac arrest patient is in need of shock therapy. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Upon receipt of the Customer Letter, users are asked to conduct a self-test on their device as per the instructions outlined in the current IFU using the details given below:
• Check the pads label for the expiry date, replace if expired
• Check the battery label for the expiry date, replace if expired
• Depress the blue “i”, listen for the voice prompt to provide device status
• Remove and reinsert the battery, allow the self-test to complete.
Users are also requested to refresh their understanding of the Audible Chirps from the AED as detailed in the Customer Letter.
This action has been closed out on 18/02/2019 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |