H6: medical device problem code 1562 added.The device was returned for analysis.The reported leak was unable to be replicated in a testing environment due to the condition of the returned device.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 did not indicate a lot specific quality issue.As there was no damage noted to the device during the inspection prior to use, it is possible that during preparation and/or during use inadvertent mishandling resulted in compromising the device; thus resulting in the reported leak difficulties and ultimately resulted in the reported material separations/noted device damages (separated faceplate/gauge, multiple breaks and smashed material throughout faceplate walls, separated gauge from the housing, separated screen at the base of the gauge); however, this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|