Model Number 5100004000 |
Device Problem
Unintended Power Up (1162)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2021 |
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: 5 events were reported for this quarter.Product return status: 2 devices were not available for evaluation.3 device investigation types have not yet been determined.Additional information: 5 devices were not labeled for single-use.5 devices were not reprocessed or reused.
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Event Description
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This report summarizes 5 malfunction events in which the device ran without user activation.5 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: 5 previously reported events are included in this follow-up record.Product return status: 5 devices were not available for evaluation.
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Event Description
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This report summarizes 5 malfunction events in which the device ran without user activation.5 events had no patient involvement; no patient impact.
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Search Alerts/Recalls
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