VYAIRE MEDICAL INC. MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE; ABSORBENT, CARBON-DIOXIDE
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Model Number MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2021 |
Event Type
Injury
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Manufacturer Narrative
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No sample nor pictures available for evaluation.The customer stated that the sample was discarded.Therefore, the root cause cannot be determined.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 that the medisorb¿ multi-absorber original, disposable experienced loss of mechanical ventilation during a case.As an intervention, they manually ventilated the patient while they swapped the machine.The customer confirmed that there was no patient harm associated with the reported event.
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Search Alerts/Recalls
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