Model Number (S)SUB MASK/SIZE 5/ADULT |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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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 that the limb-o¿ single limb anesthesia breathing circuit experienced very deflated which makes it difficult to get a quality seal to mask ventilate patients.As an intervention, anesthesia technicians manually inflate the mask via the tail valve using a syringe.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: only photos received for evaluation.Visual inspection can be seen mask is deflated.Therefore, the root cause is determined to be manufacturing process - supplier manufacturing process.
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Event Description
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The customer reported that the (s)sub mask/size 5/adult experienced very deflated which makes it difficult to get a quality seal to mask ventilate patients.As an intervention, anesthesia technicians manually inflate the mask via the tail valve using a syringe.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: sample was received for investigation.A visual inspection was performed and found the mask deflated.Therefore, reported defect was confirmed.
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Search Alerts/Recalls
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