Field service rep evaluation: the field service engineer (fse) went on-site to evaluate the suspect device.The fse cycled this ventilator oscillator device on and duplicated the reported event.The fse found a loose inspiratory limb of the patient circuit and after securing the patient circuit to the device the issue was resolved.The patient circuit calibration and performance verification test were performed, which passed.Additionally, the operational verification procedure was performed and passed.Having met manufacture specifications, the device was return for use.At this time, vyaire does not expect any further investigation.No assembly or hardware failure was identified therefore, no component root cause will be performed.
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The customer reported while in patient use, the patient was removed for patient cares.However, on re-connection to this ventilator oscillator device, the device failed to cycle.The customer stated the patient was placed on an alternate device and no patient harm or injury was associated with this event.
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