(b)(4).Additional information obtained, for clarification, from the customer states the leak was an oxygen leak from the medicine cup which would not mist.A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device, or a picture of the alleged defect, was not provided at the time of this report.A device history record investigation shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper and thorough investigation to confirm the alleged defect and determine the root cause, it is necessary to evaluate the sample involved in this complaint.If the 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 there was residue inside of the jet, jar, cap, tubing, and mask.The tubing was wrapped around the assembled nebulizer.The tubing was bent and kinked.Functional testing was performed and 5cc of water was added to the returned nebulizer unit and tubing was connected to an air flowmeter and the pressure was increased to 8 lpm.The testing was performed for 5 minutes and indicated that mist was produced and that the nebulizer did not leak.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.The device functioned as intended.
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