H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.However, the customer was informed that the low source gas indicator illuminates when the o2 level is low, and it was suggested that the 3100 be removed from the patient and replaced with another 3100, and that frantz teleau is factory trained and will inspect the unit.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device was not yet returned.
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