(b)(4).A visual, functional, and dimensional inspection of the product involved in the complaint could not be conducted since the device sample was not returned.No picture available for review.The device history records of batch number 74g1602250, 74c1602099, 74b1602791, 74b1602312, 74l1500090, 74k1500321, 74k1500320, 74j1502002 that belong to catalog number 41894, as potential lot numbers, were reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non conformance reports were originated for the lots in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.If the device sample becomes available this investigation will be updated with the evaluation results.
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(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that residue was found in the mask, jet, jar and cap.The returned sample was connected to a flowmeter and the airflow was increased to 8 lpm.A mist was produced from the chamber of the nebulizer.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.
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