Health Canada — Medical Devices · Canada · 2024-09-18 · Type II
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Reported risk: Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the device's electromagnetic immunity and emission. Degraded electromagnetic immunity can cause the monitor to generate unreadable or unusable waveforms, potentially leading to incorrect/delayed patient treatment. Excessive or unintended electromagnetic emissions can also negatively impact the function of equipment in the vicinity of the patient monitor, potentially leading to delayed procedure. Although unlikely, these scenarios could potentially result in patient harm. Recall Start Date: September 4, 2024
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