Model Number 4405000000 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2020 |
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: 7 events were reported for this quarter.Product return status: 5 devices were received.2 device investigation type has not yet been determined.Event confirmation status: 4 reported event were confirmed.1 reported event was not confirmed.Evaluation results: 5 devices had no problem found.7 devices were not labeled for single-use.7 devices were not reprocessed or reused.
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Event Description
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This report summarizes 7 malfunction events in which the device was reportedly leaking.6 events had no patient involvement; no patient impact.1 event 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 7 previously reported events are included in this follow-up record.Product return status 7 devices were received.Event confirmation status 4 reported events were confirmed.3 reported events were not confirmed.Evaluation results 3 devices had no problem found.4 devices did not have a root cause established.
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Event Description
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This report summarizes 7 malfunction events in which the device was reportedly leaking.7 events had no patient involvement; no patient impact.
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Search Alerts/Recalls
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