VYAIRE MEDICAL MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE; ABSORBENT, CARBON-DIOXIDE
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Model Number MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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At this time, the suspect device has not been returned for evaluation.At this time, no root cause could be determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Event Description
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The customer reported a leak on the 8003138 medisorb¿ multi-absorber original, disposable.The issue was detected while connected to a patient, there was no harm reported.
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Search Alerts/Recalls
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