samaritan® PAD 500P (Public Access Defibrillator)

Notice type: Advisory

Date: 18/03/2014


Product name or type:
samaritan® PAD 500P (Public Access Defibrillator)


Manufacturer Or Supplier:
HeartSine Technologies/Heartsafety Solutions

Target Audience:
Emergency Medical Technicians 
Ambulance Headquarters 
Community First Responder Schemes 
Medical Directors 
Risk Managers 
Supplies Managers 
General Practitioners 
Private medical practitioners 
Nursing Homes 
Sports clubs

Please bring this safety notice to the attention of all who need to be aware of it.

Problem Or Issue:
HeartSine Technologies is issuing a Software Upgrade to address an issue that could affect the accuracy of the CPR (cardiopulmonary resuscitation) instructions provided to rescuers by the samaritan® PAD 500P during a sudden cardiac arrest situation.

Background Information Or Related Documents:
samaritan® PAD 500P (Public Access Defibrillator) Document

HeartSine Technologies has recently issued a Field Safety Notice advising customers that the software in the samaritan® PAD 500P public access 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. 

Any samaritan® PAD 500P device manufactured between February 2010 and January 2014 with the following serial numbers inclusive are affected by this issue:

10B0010001 to 14B00461703 

HeartSine Technologies have developed a software upgrade to correct the issue. 

The Irish Medicines Board recommends customers to contact the Irish distributor and/or manufacturer to perform the software upgrade on affected devices if a date has yet to be scheduled. 

For additional details, please see field safety notice attached. 

Actions To Be Taken:
The IMB recommends that: 

1. Relevant personnel in your organisation are made aware of this potential issue. 
2. Ensure that this IMB Safety Notice and the attached field safety notice is passed on to any organisation or end user where the potentially affected devices have been transferred. 
3. Customers should contact either the local distributor or the manufacturer to schedule a service call out to upload the software upgrade to affected devices if a date has yet to be scheduled

Further Information:
Enquiries to the manufacturer should be addressed to: 

HeartSine Technologies Ltd 
Canberra House 
203 Airport Road West 
Northern Ireland 
BT3 9ED 

Telephone: +44 (0) 28 9093 9404 
Fax: +44 (0) 28 9093 9401 
Contact: HeartSine Technical Support 

Enquiries to the distributor should be addressed to: 
Irish Distributor 

Heartsafety Solutions 
Unit 17 
Kilcarbery Business Park 
Nangor Road 
Dublin 22 

Telephone: +353 1 457 8719 
Fax: +353 1 457 7659 
Contact person: David Greville 

All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 

Please click here to view a PDF version of the IMB Safety Notice

Please click here to view a copy of the field safety notice

« Back