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Catalog Number 81570 |
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 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 a 30k fsi-sli-1000 insert,pkd, alleged that the insert got hot.No injury reported.
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Manufacturer Narrative
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Returned qty.(b)4) inserts, 1.81570, 3238, 25, bul test method / (b)(4) inductance: gauge id# (b)(4) due: 11/30/2024 result: 2.47 meets spec does not meet spec n/a tip condition: - meets spec does not meet spec n/a stack condition meets spec does not meet spec n/a tested on: g136 gage id# (b)(4) due date: 03/31/2023 set pressure: 35 psi water flow: output rate: (b)(4) - meets spec does not meet spec n/a spray pattern: - meets spec does not meet spec n/a water leak: hp sealing ring proximal ring distal ring seam leak n/a vibration: - meets spec does not meet spec n/a grip condition: meets spec does not meet spec n/a other visual observation: insert laminate stack is bent.Insert was tested on a digital thermometer i.D.(b)(4) due date: 09/30/2023 and the temperature was 84.9°f is good.The specification states are not to exceed 118.4°f (per frs-9175).Alleged event: confirmed - not confirmed 2.81570, 5196, 39, bul test method / (b)(4) inductance: gauge id# (b)(4) due: 11/30/2024 result: 3.09 meets spec does not meet spec n/a tip condition: - meets spec does not meet spec n/a stack condition meets spec does not meet spec n/a tested on: g136 gage id# (b)(4) due date: 03/31/2023 set pressure: 35 psi.Water flow: output rate: (b)4) - meets spec does not meet spec n/a.Spray pattern: - meets spec does not meet spec n/a.Water leak: hp sealing ring proximal ring distal ring seam leak n/a vibration: - meets spec does not meet spec n/a grip condition: meets spec does not meet spec n/a other visual observation: insert has hp sealing o-ring water leak.Insert was tested on a digital thermometer i.D.# (b)(4) due date: 09/30/2023 and the temperature was 79.1°f is good.The specification states are not to exceed 118.4°f (per frs-9175).Alleged event: confirmed - not confirmed.
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Search Alerts/Recalls
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