The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Samaritan PAD 500P Automated External Defibrillators, manufactured by HeartSine Technologies, Inc. The affected serial numbers ranged from 10B0010001 to 14B00461703, manufactured between February 2010 and January 2014.
According to the manufacturer, the software in the concerned defibrillators may miscalculate the CPR rate of compression per minute being administered to the patient. The rescuer may, therefore, be incorrectly advised by the device to "Push Slower" when, in fact, the CPR rate is at an acceptable level.
To address the issue, the manufacturer has posted an updated version of the software for the Samaritan PAD 500P on the HeartSine Technologies website for download.
For details, please refer to the following link:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON382708
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 04 March 2014