Qn# (b)(4).The actual sample was returned, and sent to the manufacturing site for investigation.The manufacturing site reports functional testing was performed.And there were no issues with inflation and deflation of the device.There was no sign of an air leak observed, and when the device was submerged in water.There were no air bubbles escaping from the device.A device history record review was performed.And no relevant findings were identified.Based on the investigation performed, the complaint could not be confirmed.The device was able to be deflated and inflated normally.There was no air leak observed, when the cuff was inflated.The device functioned as intended.
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