| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01044-1 |
| Product Name/Description |
LifePak CR Plus and LifePak Express Automatic External Defibrillators
Serial number range: 42936349 - 44029846
ARTG Number: 138166 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Physio-Control has become aware of an issue whereby the Lifepak Plus AED or LifePak Express AED may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. The device will turn on and complete the initialisation steps, however , there are no voice prompts provided to the user and the device will enter standby mode. After 15 seconds in standby, the device will switch off. A defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. All reports received from customers have been noted during initial set up and testing of the device. To date, there have been no patient related events. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Physio-Control is providing users with instructions to follow to identify the affected units:
- Open the lid and listen for voice prompts within 5 seconds
- If the voice prompts are properly activated, press and hold the ON/OFF button for 2 seconds to turn the device off. Continue to monitor your device(s) per your established routine check process until contacted by Physio-Control to arrange component replacement for all affected serial numbers.
- If voice prompts are not activated, please remove the device from service and contact Physio-Control at 1 800 890 892 to arrange for device correction.
Users are advised to continue to monitor the device(s) per established routine check process until contacted by Physio-Control to arrange component replacement for all affected serial numbers.
This action has been closed out on the 01/11/2018. |
| Contact Information |
1800 987 982 - Physio-Control Australia |