The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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The reported issue was confirmed.The root cause identified is a failed pressure transducer.The device was evaluated upon receipt.Unit power on, pressure transducer reads 0.0 psi.After functional test, pressure transducer reads 0.0 psi.Replaced pressure transducer.Pem missing from shell.Replaced shell, coin cell.The arctic sun 5000 passed all performance testing, calibration, and electrical safety tests.The unit is ready for use.Dhr is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.The labelling review si not required as the complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.
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