Catalog Number 5100008000 |
Device Problem
Device Remains Activated (1525)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2023 |
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.1 device was received.2 device investigation types have not yet been determined.Additional information.3 devices were not labeled for single-use.3 devices were not reprocessed or reused.
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Event Description
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This report summarizes 3 malfunction events in which the device had run-on.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 run-on.1 event had no patient involvement; no patient impact.2 events 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: 3 previously reported events are included in this follow-up record.Product return status: 3 devices were received.
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Search Alerts/Recalls
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