| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00774-1 |
| Product Name/Description |
LIFEPAK 1000 Defibrillator
ARTG Number: 138166 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Physio-Control Australia has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock and deliver therapy.
The Operating Instructions provided with the device may be confusing to some customers, which has contributed to customers not replacing their battery when required. Specifically, there has been confusion regarding the readiness of the device when the OK symbol is present with a low battery charge symbol.
Additionally, a software malfunction in the LIFEPAK 1000 defibrillator that also contributes to some customers not replacing their battery when required. This results in the Readiness Display indicating a low battery charge when it should indicate a very low battery charge. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised that it is critically important to understand what the device and battery indicators mean on the defibrillator and what actions needs to be undertaken. At any time the battery charge can be verified by the instructions provided in the Operating Instructions. Batteries that are at both low battery charge and very low battery charge must be replaced with a fully charged battery, whether or not the OK symbol is present.
Physio-Control continues to investigate this issue and will have a follow up communication with customers regarding this issue. This communication may include updates to Operating Instructions, software updates or additional maintenance instructions. |
| Contact Information |
1800 987 982 - Physio-Control Inc |