MDA: Tec 6 Plus Desflurane Vaporiser
The MHRA have released a new Medical Device Alert (MDA) dated 9 November 2009.
The device concerned is a Tec 6 Plus Desflurane vaporiser and it has been discovered to have a a higher than expected age related failure of an internal component, which has resulted in either over or under delivery of anaesthetic agent to patients.
The following action is required:
• Identify all Tec 6 Plus Desflurane vaporisers. • Ensure users are made aware of the increased failure rate of these devices. • Have procedures in place to ensure that: - the vaporiser’s performance is closely monitored - the vaporiser is replaced immediately if any problem is suspected - the vaporiser performance is regularly checked, as recommended in its user reference manual in sections 6-2 and 6-3.
We urge you to read the MDA by clicking here and ensure that the actions are implemented in your workplace.
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