Ref (b)(4).Investigation: x-review dhr , x-inspect returned samples.Analysis and findings.Distribution history: this complaint unit was manufactured at csi on 9/11/17 under wo #'s 226014 & 225431 and shipped on 12/14/17.Manufacturing record review: dhr's 226014 & 225431 were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the attached 2-year complaint history showed a couple similar reported complaint conditions.No additional detail on what the issue could be was available on the complaints.New boards were put in the units and the old ones were discarded.Product receipt: the complaint unit was returned on rma 297566 under recall and received on 8/22/19.Visual evaluation: visual examination of the complaint unit revealed no physical damage.However, once the unit was opened burn damage was evident on r9 and r14 on the display board.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause : an initial investigation by technical operations (csi's engineering dept.) has indicated resistors r9 and r14 were burnt out due to being exposed to current outside their rating.The source of the power burning out the resistors has been determined to be t6, one of the transformers on the device.The root cause of this issue has been attributed to under rated resistors and lack of specification on the t6 transformer.Note: this unit is on recall 1216677-05-24-2019-002r for an unrelated complaint condition by the addition of a zener diode.Correction and/or corrective action: the recall correlates with the findings and corrections in capa (b)(4).This unit was processed per the corrective actions established pertaining to the potential for foot pedal failures.The recall units are fitted with a zener diode, but due to the additional defect finding, this unit was fitted with an entire new board under wo #(b)(4).The finding on this unit pertaining to the burnt resistors are to be addressed on capa (b)(4).No further training required at this time.Was the complaint confirmed? yes.
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