Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.However, biomed placed a new circuit on, the unit started and they smelled something burning then they are getting an oscillator topped alarm.The technical support advised based on the settings and that the driver needs to be replaced.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.
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