Catalog Number 0210112000 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/24/2019 |
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: 6 events were reported for this quarter.Product return status: 6 device investigation types have not yet been determined.6 devices were labeled for single-use.6 devices were not reprocessed and reused.
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Event Description
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This report summarizes 6 malfunction events in which the device was reportedly leaking.6 events had patient involvement; no patient impact.
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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 6 previously reported events are included in this follow-up record.Product return status 2 devices were received.4 devices were not available for evaluation.Event confirmation status 2 reported events were confirmed.Evaluation results 2 devices did not have a root cause established.
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Event Description
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This report summarizes 6 malfunction events in which the device was reportedly leaking.6 events had patient involvement; no patient impact.
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Search Alerts/Recalls
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