Model Number LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT |
Device Problem
Suction Failure (4039)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4): at this time, the suspect device has not been returned for evaluation.No root cause has been 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 2 (two) different incidents for vented yankauer and non-vented yankauer.The customer reported that the limb-o¿ single limb anesthesia breathing circuit experienced a suction problem and secretion issues while suctioning the patient.The customer confirmed that there was no patient harm associated with the reported event.
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Manufacturer Narrative
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Result of investigation: pictures and sample received for investigation.A visual inspection was performed observing that the unit has an incorrect yankuer.Therefore the defect reported by the customer was confirmed.
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Search Alerts/Recalls
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