Model Number 5400007000 |
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 09/30/2022 |
Event Type
malfunction
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Event Description
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This report summarizes 2 malfunction events in which the device had run-on.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.Reported events: 2 events were reported for this quarter.Product return status: 1 device was received.1 device investigation type has not yet been determined.Additional information: 2 devices were not labeled for single-use.2 devices were reprocessed or reused.
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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: 2 previously reported events are included in this follow-up record.Product return status: 2 devices were received.Additional information: 2 devices were not reprocessed or reused.
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Event Description
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This report summarizes 2 malfunction events in which the device had run-on.2 events had patient involvement; no patient impact.
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Search Alerts/Recalls
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