Health Canada — Medical Devices · Canada · 2017-08-14 · Type III
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Reported risk: Manufacturer has received reports of gas regulators being incorrectly set causing the device to initiate a 'no pressure too high' alarm. This problem was evaluated by the regulator manufacturer and the root cause was a production issue. Potential incorrect setting of a regulator resulting in a 'no pressure too high' alarm is not regarded a patient risk.
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