telefunken Defibrillator HPRA Warnung

HPRA warnt vor Telefunken Defibrillatoren

Seit July 2016 kein gültiges CE Zertifikat – Hersteller Defiteq nicht mehr erreichbar.

Die HPRA (Health Products Regulatory Authority) at am 4. April 2019 eine Sicherheitswarnung für Telefunken Defibrillatoren ausgegeben. In der Priority 2 Warning SN2016(15) geht es unter anderem um das fehlende CE Zertifikat. Die Herstellerfirma Defiteq International B.V. ist nicht mehr erreichbar, und hat den Vertrieb offenbar eingestellt.

Die HPRA empfiehlt Eigentümern/Nutzern von Telefunken Defibrillatoren umgehend ein alternatives Gerät zu beschaffen, da der sichere Gebrauch eines Telefunken Defibrillators nicht mehr gewährleistet werden kann.

Original HPRA Warnung:

In June 2016, the HPRA issued Safety Notice SN2016(15) on Telefunken AEDs, to highlight to users that the standby time of installed battery is 3 years. The standby time begins once the battery is placed in the AED. In addition to the battery standby time there is a battery expiration date printed on the battery pack, which users must also be aware of and follow.

The HPRA is now aware that the CE certificate for Telefunken AEDs was suspended in July 2016 and subsequently withdrawn in April 2017. Without a valid CE certificate, a manufacturer may not place on the market its devices’ and associated accessories. The manufacturer Defiteq International B.V. is uncontactable and appears to have ceased trading.

Based on our available information, the HPRA recommends owners/users of Telefunken AEDs source an alternative device. The current market performance of the device cannot be verified and the safe use of this device can no longer be assured. Furthermore, without valid market certification replacement batteries, pads and other accessories may no longer be placed on the market and any remaining stock (placed on the market prior to July 2016) may be approaching or have reached its expiration date.

ACTION OR RECOMMENDATIONS

The HPRA advises that users: 1 Replace Telefunken AEDs in your possession. 2 Forward a copy of this safety notice to all relevant personnel within your organisation and to any other organisations/persons to which/whom these devices have been transferred. 3 Contact the HPRA with any concerns.

Die vollständige Warnung (PDF) können Sie hier downloaden.

AUSTAUSCHANGEBOT FÜR TELEFUNKEN-DEFI-KUNDEN

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Bildquellen

  • telefunken Defibrillator: HPRA