Investigation.X-review dhr.Inspect returned samples.Analysis and findings.Complaint # (b)(4).Distribution history: this complaint unit was manufactured at csi on 11/04/2016 under wo (b)(4) and shipped on 04/19/2017.Manufacturing record review: dhr's 214148 & 195875 were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: this unit was serviced for a loose bj2 connector 11/26/2019.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint unit was returned on repair log 97002.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause : the product tested to specification as the device was found to meet all visual and functional test specifications.At the time, this complaint was not confirmed based on initial review of the device by service & repair.However, capa 744 has potential relevance with initial findings on an insufficiently isolated u8.The result would be a failure in coag as described on the complaint.Correction and/or corrective action the units' board was updated to the latest revision, tested to specifications and returned to the customer.Additional corrections in regard to capa 744 was the release of ecn 24379, updating a test procedure, re-working relevant units in wip and recall 1216677-09-03-2021-003 was initiated.Preventative action activity coopersurgical will continue to monitor this complaint condition for trends.
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