Model Number 5100015252 |
Device Problems
Fluid/Blood Leak (1250); Overheating of Device (1437)
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Patient Problem
Burn(s) (1757)
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Event Date 06/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.1 device was not labeled for single-use.1 device was not reprocessed or reused.
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Event Description
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This report summarizes 1 malfunction event in which the device reportedly overheated and was leaking.1 event had the patient receive a burn.
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 1 previously reported event is included in this follow-up record.Product return status: 1 device was not available for evaluation.Device not returned.
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Event Description
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This report summarizes 1 malfunction event in which the device reportedly overheated and was reportedly leaking.1 event had the patient receive a burn.
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Search Alerts/Recalls
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