Catalog Number 382-50 |
Device Problems
Device Operates Differently Than Expected (2913); Pressure Problem (3012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/16/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The results of the investigation are incomplete at the time of this report.The device history record of batch number 74b1602655 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No rejection reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.
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Event Description
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The customer alleges that the column does not hold compressible volume in the circuit while ventilating in pressure mode.When rt clamps flow tube, the column works to maintain compressible volume, but the water does not flow into the column.The patient's condition is reported as fine.No patient injury or harm reported.
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.The complaint alleged a reported difference over time in volume and/or peak pressure delivered per the reading on the servo i ventilator.Upon clamping of the upper clamp of the column, the values appeared to be go back to original values.The returned conchasmart column was inspected and found to have all components in place and functioning.The sample was subjected to simulated use testing.Tests utilized the same ventilator model as the institution and utilized all settings conveyed by the clinicians.The failure mode could not be recreated.Based on simulated testing, the event could not be duplicated.The root cause is unknown.Teleflex will continue to monitor and trend on occurrences of this type.
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Event Description
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The customer alleges that the column does not hold compressible volume in the circuit while ventilating in pressure mode.When rt clamps flow tube, the column works to maintain compressible volume, but the water does not flow into the column.The patient's condition is reported as fine.No patient injury or harm reported.
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Search Alerts/Recalls
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