Catalog Number 0210112000 |
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 09/30/2019 |
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: 4 events were reported for this quarter.Product return status: 1 device was received.1 device was not available for evaluation.2 device investigation types have not yet been determined.Event confirmation status: 1 reported event was confirmed.Evaluation results: 1 device was found to be affected by a broken battery housing port.Additional information: 4 devices were labeled for single-use.4 devices were not reprocessed and reused.
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Event Description
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This report summarizes 4 malfunction events in which the device was reportedly leaking.4 events had patient involvement; no patient impact.
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Event Description
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This report summarizes 4 malfunction events in which the device was reportedly leaking.4 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: h10 4 previously reported events are included in this follow-up record.Product return status 2 devices were received.2 devices were not available for evaluation.Event confirmation status 2 reported events were confirmed.Evaluation results 2 devices were found to be affected by a broken battery housing port.
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Search Alerts/Recalls
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