| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01036-1 |
| Product Name/Description |
LifePack 1000 Automated External Defibrillator (AED's), software version 2.42 or earlier
All lots affected
ARTG Number: 138166 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
As a follow-up to the previous communication in 2014 (TGA Ref: RC-2014-RN-00774-1), Physio-Control is correcting a software malfunction that may contribute to defibrillator batteries not being replaced when required.
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. Also, 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 |
Physio-Control will be implementing a software update in all affected devices over the next year. Updates to customer devices will be prioritised based on the age of the devices as well as the feedback provided in the response to the confirmation sheet attached with the customer letter.
In the interim, 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.
This action has been closed out on 24/10/2018 |
| Contact Information |
1800 987 982 - Physio-Control |