Model Number 4405000000 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/31/2020 |
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: 7 device investigation types have not yet been determined.Additional information: 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 insufficient information received.
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Event Description
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This report summarizes 6 malfunction events in which the device was reportedly leaking.5 events had no patient involvement; no patient impact.1 event had insufficient information received.
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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: 7 events were previously reported during the reporting period; however, 1 previously reported event in this report should have been included under mfr report # 0001811755-2021-00419.6 previously reported events are included in this follow-up record.Product return status: 4 devices were received.2 device investigation types have not yet been determined.
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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
6 previously reported events are included in this follow-up record.Product return status
6 devices were received.
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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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