Model Number FI-16RBS |
Device Problems
Fluid/Blood Leak (1250); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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If additional information becomes available, a supplemental report will be filed with the new information.This device is not distributed in us so that unique identifier is blank.This device is not marketed in us, therefore 510k is not applicable.
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Event Description
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The medical engineering department received an online report that a soft laryngoscope in the emergency intensive care ward was faulty, affecting the normal use.The medical engineer arrived at the department to check and found leakage, sent it for detection.This event occurred at the time of during inspection.There was no report of patient harm.
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Manufacturer Narrative
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Correction information: follow up #1, coding changed based on the investigation result.We couldn't investigate because the device was not returned.If additional information becomes available, a supplemental report will be filed with the new information.
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Search Alerts/Recalls
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