Catalog Number S-1130-08LF |
Device Problem
Suction Problem (2170)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device history record of batch number 74c1601966 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No rejection report was originated for the lot in question that can be associated to the complaint reported.The device history review shows that the product was assembled and inspected according to manufacturing specifications.The device investigation report has not been submitted at this time.The manufacturer will continue to monitor and trend related events.
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Event Description
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The complaint states: it does not appear that the air is being evacuated by the unit.Have re-accumulation of air with the sahara suctioning.Physicians are disconnecting and easily evacuating the air with a syringe.The patient's condition was reported as fine.
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Manufacturer Narrative
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(b)(4).Visual inspection was performed to 1 piece from product code s-1130-08lf (pe infant sahara dry suc/ seal lf 6/cs) received as part of this complaint, sample returned reflect blood residues inside the hose, no complete component are returned and its original packaging is missing.No damages directly to bottle are observed in piece.All functional tests were performed obtaining acceptable results: regulation, vacuum decay, "calibration cap" torque, inter-chamber leak test and welding integrity.No corrective actions can be established since the sample demonstrated its functionally during the inspection.The dhr reviewed showed that there were no issues related to the reported failure mode neither on the product or its components during the manufacture of this material.Functional tests was performed to unit received obtaining acceptable result.The condition reported is not observed on sample provided.The root cause for the condition reported could not be identified.(b)(4) facility will continue to track and trend this failure mode.
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Event Description
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The complaint states: it does not appear that the air is being evacuated by the unit.Have re-accumulation of air with the sahara suctioning.Physicians are disconnecting and easily evacuating the air with a syringe.The patient's condition was reported as fine.
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Search Alerts/Recalls
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