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Catalog Number 80799 |
Device Problems
Overheating of Device (1437); Temperature Problem (3022)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr 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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While using a 30k fsi-pwr-fg-1000 insert, the insert was running really hot; no injury resulted.
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Manufacturer Narrative
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Visually inspected and verified the insert has water and vibration.The insert has low water flow (partially clogged)does not meet spec.The water temperature was tested with a digital thermometer (id# (b)(4), due (b)(6) 2019).The temperature of the water is 84.0 degrees, meets spec.Specification states not to exceed 118.4° f (per frs-9175 rev.8).Upon receipt of the product, we found the incorrect catalog # and product name were submitted in the initial report.Corrected information has been included in this supplemental report.
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Search Alerts/Recalls
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