Model Number FL19H |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
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Event Description
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This report summarizes 1 malfunction event, where it was reported the device experienced an entrapment point/user entrapped in component.There was patient involvement; no adverse consequences were reported.
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Manufacturer Narrative
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The final investigation was completed, the reported issue was not confirmed via analysis of data provided by the user.
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Event Description
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This report summarizes 1 malfunction event, where it was reported the device experienced an entrapment point/user entrapped in component.There was patient involvement; no adverse consequences were reported.
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Search Alerts/Recalls
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