Catalog Number 5100015252 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2019 |
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: 3 events were reported for this quarter. product return status: 3 devices were received. event confirmation status: 2 reported events were confirmed; the cause traced to component failure.1 device evaluation is still in progress.Evaluation results: 2 devices were found to be affected by nose tip disassembly. additional information: 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.
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Event Description
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This report summarizes 3 malfunction events in which the device had a component detach.3 events had no patient involvement; no patient impact.
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Event Description
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This report summarizes 3 malfunction events in which the device had a component detach.3 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 corrected data: 3 previously reported events are included in this follow-up record.Product return status 3 devices were received.Event confirmation status 3 reported events were confirmed.Evaluation results 3 devices were found to be affected by disassembled components.
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Search Alerts/Recalls
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