Model Number 5407-200-00H |
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 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 was received.Additional information 1 device was not 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 ran without user activation.- 1 event had no patient involvement; no patient impact.
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Search Alerts/Recalls
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