H11: the device was received for evaluation.Visual inspection of the set showed cracks on both sides of the deaeration chamber.A functional air leak test was performed (2 bar pressure), and a leak was observed at the level of the deaeration chamber due to the cracks.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the observed damage was determined to be related to mechanical shock applied to the product during shipping, transport, and/or improper storage.Should additional relevant information become available, a supplemental report will be submitted.
|