| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00061-1 |
| Product Name/Description |
Efficia External Paddles
Product code: 989803196431
ARTG 281589
(Philips Electronics Australia Ltd - Physiologic-monitoring defibrillation system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/02/2023 |
| Responsible Entity |
|
| Reason/Issue |
Philips is informing that the Efficia External Paddles may not be properly identified by an Efficia DFM100 or HeartStart Intrepid Monitor/Defibrillator when connected to the device. The device may display an error message reading “Pads/Paddle Type Unknown”. When this occurs, it is accompanied by a menu prompting the user to select a therapy cable type. The message cannot be cleared until the user either selects the cable type, disconnects and reconnects the cable or restarts the device.
Three adverse events including one possible related to death have been reported to Philips which are related or may be related to this issue to date. However, none has been reported in Australia. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips are advising customers that a representative will be in contact to replace the Efficia External Paddles. Customers are also reminded to replace the paddles every three years.
In the interim, customers are advised to continue using the Efficia External Paddles with the outlined precautions in the customer letter (Will be distributed to only impacted customers by Philips). |
| Contact Information |
1800 251 400 - Service delivery team - Philips |