Health Canada — Medical Devices · Canada · 2016-09-09 · Type III
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Reported risk: Physio-Control, Inc. LIFEPAK 15 Monitor/Defibrillators with End-tidal(Et)CO2 capability are distributed with the EtCO2 setting preset to display in (millimeter of mercury) mmHg. Customers may choose to reconfigure the device to display the EtCO2, in alternative modes of (kilopascal) kPa or percent settings. When using EtCO2 in the kpa or percent setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially obscure a portion of the leading digit of the EtCO2 value. Although part of the first digit of the EtCO2 value is obscured by the respiratory rate, the capnography waveform scale automatically adapts to the EtCO2 value. Observing the capnography waveform and the range displayed will help the user confirm the patient's EtCO2 value. Clinical interpretation of a low EtCO2 value when the value is actually high could potentially lead to incorrect treatment. There have been no reports of incorrect patient treatment or harm associated with this issue.
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