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Catalog Number 80395 |
Device Problems
Overheating of Device (1437); 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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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 a 30k fsi-sli-10s insert pkd is alleged that the insert overheated.No injury occurred.
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Manufacturer Narrative
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Insert is good, no fault found.Also, insert was tested on a digital thermometer i.D.# 6116a, due date: 09/30/2023.The temperature was 94.2°, no fault found.The specification states are not to exceed 118.4°f.
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Search Alerts/Recalls
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