DS Risk Warning: Defibrillator safety warning

Hello all,

The Medicines and Healthcare Products Regulatory Agency, (MHRA) have issued the following:

Medical Device Alert

MDA/2019/027 Issued: 25 July 2019 at 14:00
Automated external defibrillators: All Telefunken HR1 & FA1 – no valid CE certificate.

The key information is as follows with the whole document, which is also attached.

Manufactured by Defiteq International BV or GGT Holding BV – the safety and performance of these devices cannot be verified and their safe use can no longer be assured.

Action

• Initiate a process for sourcing an alternative defibrillator as these devices do not meet regulatory requirements for safety and performance.

• Complete a local risk assessment for the continued use of the affected devices until an alternative device is sourced.

• Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

All the best.

Bill

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