V Series Patient Monitors 의 안전성 경고

Safety alert

2012-06-19

2012-06-19

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120619.html

Medical device safety alert: mindray v series patient monitors the medicine and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning the v series monitor, manufactured by mindray ds usa, incorporation. the manufacturer has identified two software anomalies contained in the v series monitoring system. these anomalies occur only when a vps module is connected to v12 or v21 monitor that has been monitoring a patient of a different size than the one used by the vps module. when a vps module is inserted into a v12 or v21 monitor, the two components can be synchronized so they use either the vps or the monitor settings. the two software anomalies can be summarized as follow:- a software anomaly causing the non invasive blood pressure inflation pressure and arrhythmia algorithm settings to operate based on the settings associated with the patient size previously used on the monitor instead of using the settings associated with the patient size imported from the vps. a software anomaly causing the system to utilize incorrect departmental defaults. the manufacturer advised that vps modules should not be used between systems until the software upgrade has been completed. 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 contact your supplier for necessary actions. posted on 19 june 2012.