Important Safety Alerts

Important Safety Alerts

MHRA Field Safety Notice: Mindray V series patient monitor

22 Nov 2011

The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a Field Safety Notice to alert healthcare providers and customers that a software anomaly contained in the V Series Monitor manufactured by Mindray.

According to the manufacturer, in rare instances, a system database corruption may occur that may cause the V Series Monitor to reset. The system will return to monitoring after 90 seconds, however, the database corruption may persist. Should the database corruption persist, established patient settings may be incorrect and established alarm settings, including those related to arrhythmias, may be incorrect or not available. Patient data may not be displayed or only partially displayed.

For details, please refer to the following MHRA website: 
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm

If you are in possession of the affected products, please stop using them and contact your supplier for necessary actions.

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