Model Number KE001 |
Device Problem
Activation Failure (3270)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2023 |
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.1 event was reported for this quarter.Product return status 1 device investigation type has not yet been determined.Additional information.1 device was labeled for single-use.1 device was not reprocessed or reused.
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Event Description
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This report summarizes 1 malfunction event in which the device reportedly would not expand or deploy.1 event had insufficient information received.
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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: h6, 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 reportedly would not expand or deploy.1 event had insufficient information received.
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Search Alerts/Recalls
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