The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Samaritan PDU 400, manufactured by HeartSine Technologies Ltd. The affected serial numbers are from 08P00001003 to 11P00007347.
The software of Samaritan PDU 400 device may fail to accurately determine the remaining capacity of the device battery. Rather than emitting an alarm warning users that the device has insufficient battery to deliver therapy, the device may simply shut down. The affected device may be unable to operate during a sudden cardiac arrest. The manufacturer will arrange replacement of the affected PDU 400 devices for users.
According to the regional distributor in Singapore, the affected products were not distributed in Hong Kong.
For details, please refer to MHRA website:
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 16 October 2013