Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.The customer reported that they checked the pressure sense line with no water or residual inside.They also disconnected and checked the p3 related to the frequency potentiometer as well as the regulators on the plc.For now, they have reached the maximum frequency desired but they will be monitoring this case.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.
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