Model Number 7206000000 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
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: 6 events were reported for this quarter.Product return status: 1 device was received.5 device investigation types have not yet been determined.Event confirmation status: 1 reported event was not confirmed.Evaluation results: 1 device had no problem found.Additional information: 6 devices were not labeled for single-use.6 devices were not reprocessed or 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 no patient involvement; no patient impact.
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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 no 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: 6 devices were received.Event confirmation status: 3 reported events were confirmed.3 reported events were not confirmed.Evaluation results: 2 devices were found to be affected by a corroded drivetrain.3 devices had no problem found.1 device did not have a root cause established.
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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 6 previously reported events are included in this follow-up record.Product return status 6 devices were received.Event confirmation status 3 reported events were confirmed.3 reported events were not confirmed.Evaluation results 2 devices were found to be affected by corrosion.4 devices had no problem found.
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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 no patient involvement; no patient impact.
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Search Alerts/Recalls
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