A review of the device history record revealed the device was released to stock on 09/05/2019.All documents were reviewed without issue and the device passed all tests during manufacturing.The actual complaint device was received for investigation.Our investigation included a vacuum test.The vacuum test tested all pressures measured with a calibrated manometer.All test results were within the required test requirements.Our investigation revealed the device works as intended; therefore, the reported issue was not confirmed.Based on the investigation results, no root cause could be determined.We will continue to monitor trends and utilize the information as part of continuous improvement.
|