Health Canada — Medical Devices · Canada · 2018-04-13 · Type I
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Reported risk: Draeger learned about an issue with the infinity 540 patient monitor with software versions vg4.1 and below. When the m540 patient monitor is used with and connected to the Infinity MCable Mainstream CO2 (m11.1) sensor revision 16, the m540 patient monitor will reboot if the sensor enters a reduced accuracy mode. If the m540 patient monitor reboots 3 times within a 10 minute period or less, the m540 patient monitor will go enter a fail-state, resulting in a resetting to factory defaults and loss of patient settings and stored patient data. Revision 16 sensors were introduced in mid-2017. Use of revision 15 and earlier sensors will not cause this issue to occur.
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