Catalog Number 1886 |
Device Problem
Disconnection (1171)
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Patient Problems
No Consequences Or Impact To Patient (2199); Anxiety (2328)
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Event Date 05/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved in this complaint has been returned to the manufacturer, however the investigation of said device is still in pr ogress at the time of this report.A device history record review shows that the product was assembled and inspected according to our specifications.This report will be updated at the conclusion of the device evaluation.
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Event Description
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Customer complaint alleges " on (b)(6) 2017, in atomizing chamber of pediatric outpatient department, nanjing integrated traditional chinese and western medicine hospital, doctor found the tube was dropped off the connector".Alleged event reported as occurring during use.It was reported that the "child was frightened by this event".Patient condition reported as "fine".
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.Visual inspection of the returned sample indicated that one of the connectors was not returned and was missing from the end of the tubing.Therefore, the reported complaint that the connector disconnected from the tubing was confirmed.A non-conformance was opened to address this issue.
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Event Description
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Correction to event description: event date is actually (b)(6) not (b)(6) as originally reported in the description.
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Search Alerts/Recalls
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