Catalog Number 0210114000 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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: 3 devices were received.2 devices were not available for evaluation.1 device investigation type has not yet been determined.Event confirmation status: 3 reported events were confirmed.Evaluation results: 3 devices had no problem found.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 corrected data: 6 previously reported events are included in this follow-up record.Product return status 3 devices were received.3 devices were not available for evaluation.Event confirmation status 3 reported events were confirmed.Evaluation results 3 devices were found to be affected by a broken battery housing port.
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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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