Investigation: x-inspect returned samples.*analysis and findings: complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 10/6/2006 and shipped on 10/19/2006.Manufacturing record review: a review of the device history record could not be performed as the record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the device history record be located going forward, it will be reviewed, and this complaint amended accordingly.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed one similar reported complaint condition.Product receipt: the complaint unit was returned on repair log 94951.Visual evaluation: visual examination of the complaint unit revealed physical damage.The damage is attributed to shipping.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause: no definitive root cause for this issue could be reliably determined at this time, however it is possible the patient pad was not properly used on the patient.This would be consistent with the problem description and a working unit of 14 years with no history of required service.The diaphragm was changed out due to a previous finding where the material degraded to the point where it no longer functioned as intended and prevents activation of a unit.This unit's diaphragm was in working order.However, the corrective action for this issue requires returned units be updated to the new material and applicable on this unit.*correction and/or corrective action no further corrective action is necessary, as the complaint condition was not confirmed.Corrective actions relevant to the updated diaphragm are as follows; coopersurgical service and repair replaced the diaphragm on the unit, tested it and returned it to the customer.Engineering has successfully tested a replacement material made of silicone for use in repairs going forward, eng-test-10341-r.The ifu was also updated to add a safety check via ecn-20444.A service bulletin was issued to existing customers informing them to check for this issue and return the unit if needed.All product in fg and sk, as applicable, were reworked to replace the previous versions of the dfus on all applicable products.The repaired unit will have been repaired with this new silicone material.No further training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.
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