Model Number 7208000000 |
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 01/01/2021 |
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 one (1) event was reported for this quarter.Product return status one (1) device investigation type has not yet been determined.Additional information one (1) device was not labeled for single-use.One (1) device was not reprocessed or reused.
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Event Description
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This report summarizes one (1) malfunction event in which the device was reportedly leaking.One (1) event 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 corrected data: h10 1 previously reported event is included in this follow-up record.Product return status 1 device was received.
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Event Description
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This report summarizes 1 malfunction event in which the device was reportedly leaking.- 1 event had no patient involvement; no patient impact.
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Search Alerts/Recalls
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