The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning PS500 External Power Supply Unit used with Draeger V Series Ventilators manufactured by Draeger Medical. The affected model numbers are Infinity V500, Babylog VN500 and Evita V300.
The manufacturer has become aware about events in which the battery capacity of the optional PS500 of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected. 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.
The manufacturer is advising users to only use the affected device for transport if absolutely necessary and users should not rely on the battery status indicator. Users are recommended to have a breathing bag available for manual ventilation as per the Instructions for Use.The manufacturer is also advising that if the power fail alarm occurs during transport, users should provide manual ventilation and immediately connect the ventilator to wall power to resume ventilation. Batteries on all affected devices will be replaced by the manufacturer as an interim correction, until a permanent fix can be developed.
According to the local supplier, the affected products were not distributed in Hong Kong.
For details, please refer to the following link:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00165-1
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 20 February 2014