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Catalog Number 82005 |
Device Problems
Restricted Flow rate (1248); Overheating of Device (1437); Temperature Problem (3022)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Since an overheating insert could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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Event Description
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In this event it is reported that 30k fsi-sli-fg-10s ins, pkd insert was getting hot due to no water coming out of tip end.
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Manufacturer Narrative
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Visually inspected and verify the insert has damage tip (smash).Also insert was tested on a digital thermometer id #(b)(4).Due date: 08/31/2022.The temperature is 93.5°, no fault found.The specification states are not to exceed 118.4°f.(per frs-9175 rev.9, on 4.1).
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Search Alerts/Recalls
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