| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00610-1 |
| Product Name/Description |
Optional PS500 External Power Supply Unit used in connection with Dräger V Series Ventilators: Infinity V500; Babylog VN500; Evita V300
Serial Number Range: all
ARTG Numbers: 92177 & 170141 & 158739 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
Dräger has become aware of an event in which the battery capacity of the optional PS500 did not last as long as expected. The batteries installed in the PS500 depleted much earlier than expected although the battery indicator showed a sufficiently charged battery. In 2014, Dräger issued a measure regarding similar battery capacity failures within the PS500 External Power Supply Unit. The root cause for that instance of the reduced battery capacity was due to an incorrect charging algorithm that subsequently caused sulfation within the battery. Dräger have now identified that the new batteries supplied during this exchange may be affected by a manufacturing defect that could lead to shorter battery life times.
The current analysis of the battery data available indicates that the charged battery will at least last for 30 minutes. In case of a main power loss, this 30 minutes 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 |
Affected customers will be contacted by Dräger representative to organise a battery exchange as soon as possible. Until the new batteries are installed Dräger is strongly recommending the following:
- Do not rely on the battery status indicator.
- If power fail alarm occurs, provide manual ventilation and immediately connect the ventilator to mains power to resume ventilation.
- If the hospital’s Dräger ventilators are currently used for patient transport please contact Drager Service representative immediately so that these devices will be put on priority for the battery exchange.
- Do not use the device for patient transports, unless absolutely necessary. This action has been closed-out on 22/08/2016. |
| Contact Information |
03 9244 7248 - Draeger Medical |