Coopersurgical inc.Is currently investigation the reported complaint condition.The device involved in the complaint will be returned by the customer and evaluated.Once the investigation is completed a follow up report will be filed.Ref: (b)(4).Update: investigation, review dhr, inspect returned samples.Analysis and findings: a review of the 2 yr complaint history reveals no similar issues.A review of the dhr reveals no anomalies.Service & repair did not find anything out of order during a visual inspection of the board.No cold solders were apparent, no missing components, and no damage was noted.The unit passed hi-pot testing as well.The unit works fine.The complaint is not confirmed.The pad used and returned is not dual and not a cooper recommended pad.Error on the part of end user is likely.The doctor may have produced an alternative path to ground.This cold have occurred by leaning on a patient's skin.Correction and/or corrective action: the unit was converted into a demo unit.The customer received a new unit.This complaint will be entered into the coopersurgical continuous improvement plan (cip).Reason: no applicable correction available to train to at this time.Complaints will be continuously monitored to determine if there is any new trend for this complaint condition.Was the complaint confirmed? no.
|