Health Canada — Medical Devices · Canada · 2018-07-19 · Type II
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Reported risk: The following issue is being addressed by GE Healthcare File No. FMI 36127: when multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue had been corrected. Loss of overall monitoring for a prolonged time may lead to a delay in detection of permanent or irreversible impairment or life-threatening changes in the condition of the patient.
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