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Catalog Number 80395 |
Device Problems
Overheating of Device (1437); Excessive Heating (4030)
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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 results are not available 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-10s insert,pkd insert got hot while in use.No patient injury.
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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 87.5°.The specification states are not to exceed 118.4°f.
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Search Alerts/Recalls
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