(b)(4).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.In order to perform a proper investigation and determine the source of the alleged defect reported, it is necessary to evaluate the device involved in this complaint.However material from the production line was verified and no issues were found that can lead this customer complaint.Customer complaint cannot be confirmed based only on the information provided.If the device becomes available at a later date, this investigation will be updated with the evaluation results.
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Customer complaint alleges "it was reported that: "patient was having an asthma crisis, and the nebulization was not working at all, no flow.The technician came to verify the installation.The nebulizer was changed and then it worked." it was reported there was no injury to the patient.Patient condition reported as "fine.".
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