TABLE 2. Selected clinical scenarios.

	Knowledge of device settings	Physiological feedback	Location awareness	Knowledge of parameter signal processing	Device synchronization
Devices	#1)Pulse oximeter used for sleep screening	#2)PCA pump*	#3)Finger pulse oximeter and BP cuff on the same arm	#4)EHR and medical device data	#5)X-Ray/Bypass and ventilation, or Oxygen and Laser devices in use *
Cause	Averaging time in a pulse oximeter is variable and may not be made known to the user/app	Architecture or device defect; device not capable of acknowledging, no feedback signal was architected into the platform	Inflation of cuff and monitoring of SpO2 at the same time on same limb. State of NIBP not made known to App so that it can ignore the SpO2 data	Clinically relevant events may not be captured in EHR	Failure to ventilate after X-ray procedure or resumption of cardiopulmonary bypass or failure to lower oxygen fraction during airway laser use.
App or System failure mode	Transient desaturation will be missed; data does not map/match to actual physiological parameter	Unknown whether command was followed or seen by pump. Unknown what state pump is in.	State of NIBP not known to App. It can ignore SpO2 data. App misinterprets SpO2 signal.	State and context may not be known	State of ventilator not known to X-ray or bypass machine. State of O2 delivery unknown to laser device.
Local failure effect	App underdiagnoses severity of respiratory depression due to sleep apnea.	Medication overdose; App keeps seeing physiological information that is in conflict with pump stopped.	False positive desaturation leading to stopping infusion inappropriately; false positive indication of probe unreliability	Rapidly changing clinical event may not be captured in patient record leading to failure to properly treat condition	Failure to ventilate leading to hypoxia Failure to lower oxygen levels leading to airway fires
Larger systemic effect	Injury or death	Injury or death	App fails to run as intended	Injury or death	Injury or death
System hazard/ requirement	App needs to know averaging time	pump state needs to be available to confirm stop command	NIBP should communicate the status of cuff inflation and location	State and context need to be captured by EHR-including clinical data-sufficient time resolution	Ventilation Disable should be limited in time, linked to alarms and synched to therapeutic devices
General class of hazard	State of the device was not conveyed to the app	Indication of state of the device not conveyed to the app; defect in command and control.	Context (device placement) and State (measurement event synchronization) of device needed to make correct decisions	Context and state not conveyed to EHR	Operational state of devices need to be shared on a timely basis
Patient Context	Patient in sleep lab.	Hospitalized patient in bed on PCA infusion pump.	BP cuff proximal and ipsilateral to SpO2 probe	Clinically relevant events not recorded- care may be impacted.	Ventilation Paused means patient is at risk for hypoxia. O2 concentration not lowered means risk of fire and burns
Device and Patient States (future)	Device: Oximeter in “fast mode” and patient not moving enables system to distinguish oxygen desaturation from noise caused by patient movement	Device: PCA pump and physiologic sensors interoperable Patient: early respiratory depression detectable	Device: Inflated BP cuff with SpO2 probe distally located Patient: artifact on SpO2 identified	Device: medical device with settings known to EHR Patient: transient events recorded	Device: Ventilator with X-ray or O2 device with Laser Patient: lack of ventilation or excess O2 detected
Device-device interaction	Device configuration (operational state) based on clinical status	Pump must be able to process external stop command and change its own state	SpO2 must be aware of NIBP state to avoid errors	Lack of complete data set inhibits clinical interpretation	State of O2 device must be known, exchanged, and synchronized with laser device

^*These scenarios are based on content from Annex B of ASTM F2761 [8].