Vyaire medical file identification: (b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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It was reported to vyaire medical that the ventilators display is blank.The unit is powered up, green ac light, but no display.The biomed found a note on the vent that just said the display does not work.When he powers the unit on the display remains blank and the unit has a constant alarm.Not sure if patients were involved or not.
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