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Safety alert issued for anaesthesia machine

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety alert reporting a risk of loss of ventilation and inadequate anaesthesia with Datex-Ohmeda Aisys Carestations.

The defects may lead to ventilation loss, inadequate anaesthesia and hypoxia or severe hypotension.

The manufacturers, GE Healthcare, have reported safety issues with the Datex-Ohmeda Aisys CS2 and Aisys anaesthesia devices with software version 11 and version 11 SP01 that may stop ventilation when in PSVPro Mode, and users may be unable to change gas and agent settings when using End-Tidal Control. When using PSVPro Spontaneous Breathing Modes, if the patient does not start or stop spontaneous breathing after the cycling procedure has completed, there will be no backup ventilation.

The MHRA is advising that, before using affected modes, clinicians should undertake an appropriate risk assessment and document their reasoning for continued use.

If using the device in PSVPro or End-Tidal Control modes, additional patient monitoring should be used to ensure that patient safety is not compromised.

GE Healthcare should be contacted directly to arrange the installation of a software update.

For devices are not using software version 11 or 11 SP01, no further action is required.


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