Unit nurse manager (unm) reported the patient was transported to operating room (or) at approximately 10:30 am on (b)(6) 2021 and returned back to the unit at approximately 12:50 pm.When the patient returned back to their room, the patient was reconnected to the telemetry device but monitoring did not start for a couple hours.Unm stated that telemetry device was in standby mode from time: 12:52pm-15:04 pm.Monitoring did resumed at 15:04pm.The unm reported that at approximately 3:09 pm they received an asystole alarm for patient and when they went to check on the patient, the patient coded; the patient did pass away (death).Unm states the mx40 was in standby and never came out of standby until patient was already deceased.The customer doesn¿t know the reason for the mx40 not coming out of standby and would like an explanation as to what caused the issue.The patient died.
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Unit nurse manager (unm) reported the patient was transported to operating room (or) at approximately 10:30 am on (b)(6) 2021 and returned back to the unit at approximately 12:50 pm.When the patient returned back to their room, the patient was reconnected to the telemetry device but monitoring did not start for a couple hours.Unm stated that telemetry device was in standby mode from time: 12:52pm-15:04 pm.Monitoring did resumed at 15:04pm.The unm reported that at approximately 3:09 pm they received an asystole alarm for patient and when they went to check on the patient, the patient coded; the patient did pass away (death).Unm states the mx40 was in standby and never came out of standby until patient was already deceased.The customer doesn't know the reason for the mx40 not coming out of standby and would like an explanation as to what caused the issue.The patient died.
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A philips field service engineer (fse) went to the hospital campus and obtained audit logs to include the rfda and device debug logs, as well as mx40 pwm log.A philips product support engineer (pse) reviewed the information provided in the audit and mx40 pwm log.The pse determined the mx40 pwm log that was provided was incomplete.Audit log review: the pse¿s review of the audit log confirms that the mx40 was put into standby mode at the mx40 at 10:11 am on (b)(6) 2021.The device was taken out of standby mode at the mx40 at 15:05 pm on (b)(6) 2021.The device was in standby mode for 4 hours and 54 minutes.When the device came back online at 15:05 pm on (b)(6) 2021, an asystole alarm was generated.While the device is in standby mode, no monitoring is being performed and ¿tele standby¿ inop is displayed at the patient sector of the information center according to page 9-27 of the instructions for use (ifu).Based on the standby time of 4 hours and 54 minutes, the standby duration that was configured for the mx40 was infinite.Page 143 of the intellivue mx40 ifu states about standby duration control: sets the standby duration time when standby is selected at the iic.Note ¿ standby duration can also be set at the mx40.The standby time period may differ between the device and the default setting at the information center.The duration is determined by the location of the standby selection, i.E.Placing the mx40 in standby mode at the device or at the information center.When the mx40 comes out of standby at either location, the device is activated in both locations.Settings: infinite, 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours.Factory default: infinite.Rfda log review: the pse¿s rfda log review confirms the device went offline on (b)(6) 2021 at 10:11 am when it was placed in standby mode.The device exited standby mode on (b)(6) 2021 at 15:05 pm.Device debug log review: the pse¿s device debug log review confirms the device went offline on (b)(6) 2021 at 10:11 am when it was placed in standby mode.The device debug log shows the device restarting (coming out of standby mode) on (b)(6) 2021 at 15:05 pm.Based on our investigation, philips has determined the mx40 was working as designed.The information as provided to the customer.The device remains at the customer site.
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