Telefunken HR1 FA1 and HeartReset defibrillators do not have CE marking from 2016

The Dutch manufacturer of automatic external defibrillators DefiTeq entered the Spanish market with its DEA Telefunken. Seduced by their low prices, both public and private entities have been acquiring these DEA devices, considerably increasing their implementation in Spain in the last 3 years. However, the problems soon appeared.

 

The Telefunken “HR1” and “FA1” defibrillators and HeartReset with a false CE marker


The Spanish Agency for Medicines and Health Products (AEMPS), through a informative note on their website, has warned that Automatic external defibrillators (AEDs) of the Telefunken and HeartReset models have a false CE marker. Thus, by not having a valid CE certificate, they have been manufacturing a defibrillator without the guarantees of safety and operation.

Some European health organizations such as the HPRA in Ireland have also published public safety notices against Telefunken's DEA, advising the owners and users of the device to obtain an alternative defibrillator with CE marking

 

The importance of having defibrillators with CE marking


AEDs are life-saving tools and are designed to be used by the general public or by professionals in case of emergency. People trust these devices to work when necessary. Failure to properly address the necessary safety and security actions required by marking, puts people's lives at risk.

The Agency's recommendation in these cases is not to use the AEDs of these models. If you have a Telefunken “HR1” and “FA1” or HeartReset model defibrillator manufactured after the 18 of July of 2016, you are advised to "Proceed as soon as possible to replace it with another defibrillator with a valid CE certificate".

 

New defibrillators with current CE certificate available in Spain

 

The market for semi-automatic defibrillators has matured considerably in recent years, improving on traditional voice prompts and simple metronome functions. Currently we can find defibrillators with LCD screen and universal adult / pediatric electrodes in a single patch.

In addition, the new external defibrillators incorporate sensors that are capable of measuring the depth of the compressions, informing the user in real time about the quality of the thoracic compressions that are administered, ensuring good blood circulation to the brain, heart and other organs. . Wi-Fi connectivity has even been added in some models to offer remote monitoring of the 24 hours unit.

Customers who would have been attracted by the economic price of the cheap Telefunken defibrillator can be sure that there are cost-effective alternatives available in the market that provide a set of features such as real compression aids and a safe defibrillation of the patient, thus providing CE marking as the defibrillator Zoll AED PLUS o Zoll AED 3.

 

The definitive alternative to the Telefunken defibrillator: Our Plan renovates defibrillators


From Project Lifeguard we offer a renewal plan to all those entities that have a Telefunken defibrillator.


Our cardioprotection services that include:

 

  • ZOLL AED PLUS Defibrillator Complete or ZOLL AED3 in renewal plan. Both with CE certificate.
  • Showcase with alarm and daylight night.
  • Official ILCOR location posters and algorithm poster.
  • Online training course for other workers not trained in person.
  • Help in the registration and registration of students and defibrillators in the autonomous community, being essential to have defibrillators with CE marking.
  • 10 RC Insurance Millions of Euros.
  • FREE APP geolocation "SALVAVIDAS PROJECT".
  • Comprehensive maintenance and total warranty, including spare parts for use or expiration.
  • Support 24 hours by free phone 900 670 112.
  • Post-use management with free defibrillator delivery, including data download.
  • All the necessary elements to register the equipment and during the 60 months.
  • Adaptation to future national and Autonomous Community regulations.
  • Cardioprotected Space Certificate.

  

Our advice on substandard or counterfeit defibrillators 

Counterfeit medical devices may cause harm to patients and may not be effective in the treatment of emergencies to which they are intended. Counterfeit medical devices generate lack of confidence in technology, healthcare professionals and health systems.

Before buying any semi-automatic defibrillator, we advise you to ask for the CE marking of the device, because apart from being a synonym for quality, guarantee and safety, it is an indispensable requirement when registering in your autonomous community. In addition, the health inspectors will notice that your defibrillator has this marking and will require you to present the corresponding documentation, otherwise it will be grounds for sanction.  

For more information do not hesitate to contact our team. We will be happy to help you.

Phone: 900 670 112
E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

 


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