Field service rep (fsr) evaluation: a vyaire field service representative (fsr) from biomed evaluated the device onsite, , it was visible in the initial investigation that device's power setting was set to 0.The field service representative ran the device for 8 hours and performed a patient circuit cal and vent performance check.As a resolution, the device was subjected to further testing including: dc power supply voltages check, calibration of airway pressure monitor xdcr, driver displacement indicator check and completed alarm tests.The fsr repeated patient circuit cal and vent performance check on the device.The field service representative confirmed the ventilator was ready to be used on a patient.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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