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Catalog Number 81309 |
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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Event Description
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In this event it is reported that select sps swvl/reserv,120v ex during use, customer alleges that the insert was getting hot while in use with this device.No injury occurred.
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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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Manufacturer Narrative
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Investigation results: no fault was found with returned unit.Dhr review is not required because the product was returned for evaluation.Root cause: no defect proven conclusion code: no failure found.
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Search Alerts/Recalls
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