| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00165-1 |
| Product Name/Description |
PS500 External Power Supply Unit used with Dräger V Series Ventilators
Models: Infinity V500; Babylog VN500; Evita V300
ARTG Number: 158739 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
The batteries installed in the PS500 deplete much earlier than expected although the battery indicator showed a sufficiently charged battery. In some cases neither the “Battery Low” nor the “Battery depleted” alarm was given, when the remaining battery capacity fell below 10%. Available data indicates that the charged battery will last for at least 3 minutes. In case of a main power loss, this 3 minute battery back-up should typically be sufficient until the emergency main power supply is re-established. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Draeger is advising users to only use the affected device for transport if absolutely necessary and users should not rely on the battery status indicator.
Draeger is recommending users have a breathing bag available for manual ventilation as per the Instructions for Use (IFU).
Draeger is advising that if the power fail alarm occurs during transport, provide manual ventilation and immediately connect the ventilator to wall power to resume ventilation.
Draeger is advising that the batteries on all affected devices will be replaced as an interim correction, until a permanent fix can be developed. |
| Contact Information |
1800 800 327 - Draeger Medical Australia Customer Service |