Catalog Number 3500000710 |
Device Problem
Unintended System Motion (1430)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
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 un-commanded motion.There was no patient involvement.
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Manufacturer Narrative
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The device that was pending was evaluated and it was determined the device experienced product does not move to, and/or stay in, desired position, which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from 1 to 0.
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Event Description
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This report summarizes 0 malfunction event, where it was reported the device experienced un-commanded motion.There was no patient involvement.
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Search Alerts/Recalls
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