There is no 510(k) for this device as it is manufactured outside the us and not sold in the us.(b)(6).Results: two samples were returned for evaluation.A visual inspection revealed the samples were unused and in sealed packages.A simulated use test was conducted and the safety mechanisms of both units were activated successfully.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6231295.A manufacturing review revealed no abnormalities with incoming material, the assembly process, or the packaging process.Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.(b)(4).
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