Model Number FI-16RBS |
Device Problem
Optical Problem (3001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This device is not distributed in the usa, therefore the pma/510(k) number is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.
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Event Description
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Completed the inspection and started during use, the light source disappeared and could not use.Stopped using and replaced another one to continue.This event occurred at the time of during use.There was no report of patient harm.
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Manufacturer Narrative
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Evaluation summary: no repair has been made.The battery had run out of power.The light source could not be lit.The hospital replaced the battery.And the problem was solved.Correction information: h6: coding changed, based on the investigation result.
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Search Alerts/Recalls
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