Visual and functional analysis was performed on the returned device.The reported inflation issue and leak was not confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the inflation device was not properly connected to the sidearm; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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