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Samaritan PAD 300/PAD 300P Automated External Defibrillators

Notice type: Advisory

Date: 17/12/2012

  

Product name or type:
Samaritan PAD 300/PAD 300P Automated External Defibrillators

Reference:
SN2012(19)

Manufacturer Or Supplier:
HeartSine Technologies Ltd

Target Audience:
General Practitioners 
General Public 
Community First Responder schemes 
Risk Managers 
Hospitals 
Nursing Homes 
Schools 
Sports clubs

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

Problem Or Issue:
The Samaritan PAD 300/PAD 300P automated external defibrillators (AEDs) may not deliver therapy.

Background Information Or Related Documents:
The manufacturer HeartSine Technologies initiated a field safety corrective action (FSCA) on the Irish market relating to their Samaritan PAD 300/PAD 300P AEDs. A field safety notice (FSN) was distributed by HeartSine in September 2012 detailing 2 issues that can affect certain Samaritan PAD 300/PAD 300P serial numbers: 

Issue 1(On/Off Issue): The device may turn itself on without input from the user. If the device does not detect that the audible prompts emitted after the device turns on are followed the device will automatically switch off after 10minutes to save power. If this sequence of events occurs repeatedly the battery of the device may deplete below the minimum battery capacity required for the delivery of therapy. 

Issue 2 (Battery Management Software Issue): Certain PAD 300/PAD 300P devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signalling a low battery. If the low battery warning is triggered due to this issue the device may turn itself off. 

Please refer to the attached FSN for additional details on the issues affecting the devices, the list of affected serial numbers and the actions proposed by the manufacturer. 

HeartSine Technologies has informed the Irish Medicines Board (IMB) that the FSN has been distributed to all of their customers in Ireland. However, to date only a small percentage of users have confirmed receipt of the FSN and requested the upgrade kit required to carry out the recommended actions. HeartSine Technologies advises that all customers should contact them immediately if they identify that they have such a device and to arrange completion of the necessary actions. 

Samaritan PAD 300/PAD 300P Automated External Defibrillators Document

Actions To Be Taken:
1. Ensure that the relevant personnel in your organisation are made aware of the two issues. 

2. Determine if you have purchased a device that is affected by this FSCA by reviewing the attached FSN. 

3. If you have an affected device, please contact HeartSine Technologies immediately to arrange for the recommended actions to be carried out. 

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

James McGuinness 
HeartSine Technologies Ltd. 
203 Airport Road West 
Belfast 
BT3 9ED 
Northern Ireland 

Telephone: +800 1212 5555 
Email: data@heartsine.co.uk 

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 
E-mail: devicesafety@hpra.ie
Website: www.hpra.ie

Please click here to view PDF version of this safety notice

Please click here to view copy of field safety notice

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