News

Recall for Product Correction - SAM500P Defibrillator

Thursday, March 27, 2014

HeartSine Technologies samaritan® PAD 500P (Public Access Defibrillator) Software upgrade


TGA Reference Number: RC-2014-RN-00243-1

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 older model samaritan® PAD 500P public access defibrillators

Please note this is simply resolved by a software upgrade which completely corrects the issue. The inherent technology is completely effective and has been responsible for saving countless lives.

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 Urgent Recall for Product Correction relates to this secondary function. The software in older model 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

Corrective action related to the samaritan® PAD 500P

To address the issue described in this Field Safety Notice, an updated version of the software (3.4.0) for the samaritan® PAD 500P is now available. The updated software has been posted on the HeartSine Technologies website ready for download.

If you already have a HeartSine data cable and internet access, please follow the instructions in Annex I of this Recall for Product Correction and fill out the response card in Annex II.

If you do not have a HeartSine data cable or internet access, you should ask Aero Healthcare, using the Response Card in Annex II, to send you an upgrade kit. When you receive the upgrade kit, follow the instructions provided, in order to upgrade your device software.

Do not remove the device from service.

If you have any questions, please call Aero Healthcare at 1800 628 881.

If you have further distributed your samaritan® PAD 500P, please notify your customers at once of this communication. Please also provide Aero Healthcare with the customer's contact information so that we can follow-up with the current owner of the device.

This action has been undertaken after consultation with the Therapeutic Goods Administration (TGA)

We appreciate your understanding as we work to ensure that we are providing you with the most up to date and reliable devices you have come to trust.

Sincerely,

Tim Ovenden
Managing Director
Aero Healthcare


Download PDF here for more information on this recall

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