Clinic notes were received providing settings from a visit on (b)(6) 2015 and (b)(6) 2016.History in the notes indicated that the device may have been at settings indicative of a faulted diagnostics test with an off time of 60 seconds.Review of the manufacturer's in-house programming history revealed the last programmed settings also had an off time of 60 seconds from the date of (b)(6) 2014.The output current had been corrected by the physician in the same visit, but the off time had been left uncorrected at 60 seconds.The off time was adjusted to 1.1 seconds by the physician on (b)(6) 2016.Additional relevant information has not been received to-date.
|