Reported event: an event regarding a non functional jts drive unit was reported.The event was confirmed by product inspection.Method & results: device evaluation and results: visual inspection: pictures of the jts power unit, jts coil, and documentation were taken.Visual inspection of the jts power unit reported, showed signs of minor external damage, on top of the unit casing a small dent was found.On the back of the power unit, the plastic covering protecting the boost feature is exposed but appeared intact with no visible damage, however just below the plastic, the black protective end cap has moved out of position, extending outwards.On the side of the unit the label reporting annual maintenance is present and in date.The jts coil also did show minor visible damage, a few scratches were found across the coil whereby the purple coat was scratched off.Both the magnetic coil and the power unit console share the same serial number (b)(6) and both devices state the date of manufacture is ¿apr-18¿.Functional inspection: the branch operations manager (north texas branch) reported that the functionality test was performed.It was reported "bad power supply [.] no rotation [.] 01 is base gauss meter.No gauss detected.Roughly 3 minutes in, power unit shuts off.Doesn't come back on for a minute or two.Additionally, doesn't power down immediately.A/b direction toggle loose".Clinician review: no medical records were received for review with a clinical consultant.Device history review: the last annual maintenance was performed on the (b)(6) 2020.The unit passed the annual maintenance without any reported discrepancies.Complaint history review: there have been no other events for the serial number referenced.Product surveillance will continue to monitor for trends.Conclusion: an event regarding malfunction of a jts drive unit was reported.The event was confirmed by product inspection.The functional inspection determined the unit presented a "bad power supply", "no rotation", and "no gauss detected".The jts drive unit has been sent for repair.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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