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Catalog Number 80395 |
Device Problems
Restricted Flow rate (1248); No Flow (2991); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that customer purchased 3x slimline cavitron tips on 1st october, one of which appears to be faulty.There is no water coming through and the tip gets very hot - no patient injury reported.
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Manufacturer Narrative
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While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
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Manufacturer Narrative
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Insert has no water flow.Clogged.Insert will get warm if you continue to run without water flow, as for any insert.
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Search Alerts/Recalls
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