Model Number 5100015250 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/31/2021 |
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: 10 events were reported for this quarter.Product return status: 9 devices were not available for evaluation.1 device investigation type has not yet been determined.Additional information: 10 devices were not labeled for single-use.10 devices were not reprocessed or reused.
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Event Description
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This report summarizes 10 malfunction events in which the device was reportedly leaking.10 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: 10 events were previously reported during the reporting quarter; however, - 1 event was reported in error.- 9 previously reported events are included in this follow-up record.Product return status: 9 devices were not available for evaluation.
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Event Description
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This report summarizes 9 malfunction events in which the device was reportedly leaking.- 9 events had no patient involvement; no patient impact.
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Search Alerts/Recalls
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