Catalog Number 031-33J |
Device Problems
Unstable (1667); Device Fell (4014)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved was reported as returned, however said device has not been received by the manufacturer at the time of this report.The device history record (dhr) of the product 031-33j batch number 74h1701585 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No nonconformance reports were originated for the lot in question that can be associated to the complaint reported.All materials used during the assembly met current specifications.Dhr shows that the product was assembled and inspected according to our specifications.No conclusion can be established at this time based on the lack of device of sample.A follow up report will be submitted once the device is received and the evaluation is completed.
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Event Description
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Customer complaint alleges "the connection part assembly to the flowmeter was unstably attached to the adaptor, and fell out".Therefore, a new unit was used instead.Alleged issue reported as occurred during patient use.No patient injury was reported.The patient condition was reported as "fine".
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Manufacturer Narrative
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Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the adaptor was missing.It was not possible to perform the oxygen entrainment testing due to the missing component.As additional testing purposes, one component part number tfx-001743 (adaptor, snap-on flowmeter resin re-0042) was taken from the assembly line and assembled on the sample.After that, the sample was tested on the oxygen entrainment testing.During the testing no issues or discrepancies were found that can lead to the condition reported by the customer.The complaint could not be confirmed and a root cause was not established as the sample was received with a missing component.
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Event Description
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Customer complaint alleges "the connection part assembly to the flowmeter was unstably attached to the adaptor, and fell out".Therefore, a new unit was used instead.Alleged issue reported as occurred during patient use.No patient injury was reported.The patient condition was reported as "fine".
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Search Alerts/Recalls
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