Software Upgrade for Samartian for Product Correction - 500P Defibrillator

Tuesday, May 06, 2014
HeartSine Technologies samaritan® PAD 500P (Public Access Defibrillator) Software upgrade

Dear Owners of the samaritan® PAD 500P,

The purpose of this letter is to inform you of a corrective action that HeartSine Technologies Ltd. is introducing in relation to samaritan® PAD 500P public access defibrillators.

The corrective action is intended to address an issue that could affect the accuracy of the CPR (cardiopulmonary resuscitation) instructions provided to rescuers by the samaritan® PAD 500P Defibrillator during a sudden cardiac arrest situation. HeartSine Technologies’ records indicate that you have received a samaritan® PAD 500P device which is affected by this action.

Issue identified

The samaritan® PAD 500P Defibrillator is intended, where appropriate, to deliver shocks to victims of a sudden cardiac arrest and has a secondary function to provide feedback to rescuers concerning the effectiveness of the CPR they are providing.

The corrective action described in this Upgrade is for Product Correction relates to this secondary function. The software in your samaritan® PAD 500P 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. There are reports of death and serious injury during the use of the samaritan PAD 500P devices, and in two cases the incorrect CPR feedback given to the user cannot be eliminated as being a contributory factor to the patient outcome. Any samaritan® PAD 500P Defibrillator devices manufactured between February 2010 and January 2014 with the following serial numbers inclusive are affected by this issue:

· 10B0010001 to 14B00461703

Download PDF here for more information on this software upgrade