Additional information was provided in sections d.10, h.6 and h.10.The regulator failed for high flow, but was able to be adjusted to meet specifications.The unit also failed for dead end pressure.The dead end pressure would not stop climbing, no other testing could be performed.Although the customer complaint could not be confirmed, the regulator does not meet release criteria.No investigation into the perfluropropane product could be performed as there was insufficient information provided.A check of the batch production record for regulator from this lot, showed no unusual manufacturing issues.A check of the batch production record for the perfluropropane cylinder could not be performed because a valid lot number was not reported.The expiration date could not be determined.A check of the complaint records showed two other complaints against regulator this lot.A check of confirmed complaints for perfluropropane eye gas not lasting as long in the patient's eye as expected showed no complaints since the beginning of 2016.A check of confirmed complaints for regulators with low or no flow showed 27 complaints since the beginning of 2015.One regulator of this lot was in good condition as received.The regulator was put through final test and inspection.Based upon the information, the root cause of the reported event cannot be determined.At this time, the root cause of the reported event cannot be determined.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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