Qn#(b)(4).No complaint product was returned for investigation.However, customer has provided the sample of foreign matter.Complaint reported that filters are leaving fibers in their breathing circuit.Sample foreign matter fiber has returned for investigation without the actual complaint product.The complaint on foreign matter was not confirmed.There is no similar material like fiber use as the component of the assembled product.Furthermore, complaint reported that fibers were detected within the breathing system on the expiration side, and it may not cause from the product itself.In current manufacturing procedure, 100% visual inspection after assembly process is conducted.Thus, any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the product having foreign matter to be released for shipment.Visual inspection of any foreign matter will be culled out during inspection.The foreign matter may be caused from contamination during handling process.Therefore, this complaint could not be confirmed.Other remarks: n/a corrected data: n/a.
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