Catalog Number 0210100000 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 12/31/2019 |
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: 8 events were reported for this quarter.Product return status: 7 devices were received.1 device was not available for evaluation.Event confirmation status: 7 reported events were confirmed.Evaluation results: 7 devices were found to be affected by a broken battery port.Additional information: 8 devices were labeled for single-use.8 devices were not reprocessed or reused.
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Event Description
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This report summarizes 8 malfunction events in which the device was reportedly leaking.8 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 corrected data: b5, h10 8 events were originally reported for this failure mode during the reporting quarter.- 1 event was inadvertently excluded.- 9 reported events are included in this follow-up record.Product return status 8 devices were received.1 device was not available for evaluation.Event confirmation status 8 reported events were confirmed.Evaluation results 8 devices were found to be affected by a broken battery housing port/stem.
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Event Description
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This report summarizes 9 malfunction events in which the device was reportedly leaking.9 events had patient involvement; no patient impact.
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Search Alerts/Recalls
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