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Defibtech DDU-100 series AED marketed under the brand names Lifeline AED, ReviveR AED and Lifeforce AED

Notice type: Advisory

Date: 17/12/2012

  

Product name or type:
Defibtech DDU-100 series AED marketed under the brand names Lifeline AED, ReviveR AED and Lifeforce AED

Reference:
SN2012(18)

Manufacturer Or Supplier:
Defibtech LLC

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:
Certain Defibtech DDU-100 series AEDs marketed under the brand names Lifeline AED, ReviveR AED and Lifeforce AED may not deliver therapy.

Background Information Or Related Documents:
The manufacturer, Defibtech LLC, initiated a Field Safety Corrective Action (FSCA) on the Irish market in March 2011 relating to certain Defibtech DDU-100 series automated external defibrillators (AEDs) shipped with 2.004 software or earlier. These devices are marketed under the brand names Lifeline AED, ReviveR AED and Lifeforce AED. The issue was communicated in a field safety notice (FSN) distributed in March 2011. 

There are two conditions that may cause the affected devices to cancel shock during the charging process. Please refer to the attached FSN for details on the two conditions and the manufacturer’s recommended actions. 

Defibtech LLC has informed the Irish Medicines Board (IMB) that Defibtech and its distributors have attempted to distribute the FSN to all affected customers in Ireland. However, despite repeated attempts to contact their customers the manufacturer has not had sufficient confirmation from all end customers that they have received the FSN and completed the recommended actions. Defibtech LLC advises that such customers should contact their local representative, Safety Ireland, (see contact information below) or Defibtech directly if they identify that they have such a device. 

Defibtech DDU-100 series AED marketed under the brand names Lifeline AED, ReviveR AED and Lifeforce AED Document

Actions To Be Taken:
1. Ensure that the relevant personnel in your organisation are made aware of the attached FSN and its content. 

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

3. If you have an affected device, please follow the instructions provided by Defibtech LLC in the attached FSN. 

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

Defibtech Technical Support 
Defibtech LLC 
741 Boston Post Road, Suite 201 
Guilford 
CT 06437 
USA 
Email: techsupport@defibtech.com 
Telephone: +1-203-453-4507 
08:30 to 17:30 (GMT – 4:00) Monday - Friday 

Or to Defibtech LLC’s European Authorised Representative: 

Emergo Europe 
Elizabeth Pugh 
Molenstraat 15 
2513 BH, The Hague 
The Netherlands 
Tel.: +31 70 345 8570 
Fax: +31 70 346 7299 
Email: vigilance@emergogroup.com 

Or to Defibtech LLC’s local representative: 

James Butler 
Safety Ireland First Response Limited 
Unit 52, Fortfield Park 
Terenure 
Dublin 6W 
Ireland 
http://www.defibtech.ie 
Callsave: 1850 555 999 
Phone: +353-1-442 2999 
Fax: +353-1-442 3040 
E-mail: info@defibtech.ie 

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 a PDF version of this Safety Notice

Please click here to view the field safety notice

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