ITS4850A IntelliVue Telemetry System-Monitor

When the MX40 is in standby mode for an extended period without patient surveillance no monitoring or alarming is available because alarms, as designed, cannot be triggered when the MX40 is in standby mode.  When users place the MX40 device in standby mode, there are 2 possible outcomes: 

1) If a timed duration (i.e., 10 minutes to 4 hours) is used for standby, the MX40 will automatically resume monitoring and end standby mode at the end of the time period; or 

2) If infinite duration is used for standby mode, the device will not resume monitoring until standby is manually ended by the user or a "tele battery low" inop condition occurs. While the MX40 device is in standby, physiological monitoring and alarming is stopped. 

Therefore, there may be a hazardous situation present if a user places an MX40 in standby longer than intended for completion of a patient procedure or test if the device is not taken out of standby.

Recall start date: June 2, 2023