Health Canada — Medical Devices · Canada · 2015-09-29 · Type II
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Reported risk: Fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt Propaq LT device operations. If this unlikely event were to occur, the device would either present an error screen instructing the user to restart the monitor, or could instead present a blank or white screen. Either screen would be accompanied by one or more blinking led lights, and in either case, the issue would be resolved by restarting (power cycling) the monitor. There is no risk associated with this issue other than a very short delay in obtaining patient vital signs from the Propaq LT while the device is restarted.
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