VYAIRE MEDICAL LIMB-O SINGLE LIMB ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Model Number LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT |
Device Problem
Disconnection (1171)
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Patient Problem
Apnea (1720)
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Event Date 10/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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According to the customer, the sample used by the patient was discarded in the hospital.In order to have the investigation, they have received an unused reference sample from the hospital.But only the unused sample photos will be investigated.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 disconnection with the air filter and circuit after anesthesia with the patient.Later, the patient became pea and took life-saving measures, and noticed that the air filter and circuit had been disconnected again after the heartbeat resumed.As an intervention, when the patient had pea (pulseless electrical activity; it means a cardiopulmonary arrest), a resuscitation was attempted.And then, the cardiopulmonary of the patient has regained.The hospital indicated that the patient may have become apnea due to the disconnection between the circuits.
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Manufacturer Narrative
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Result of investigation: the pictures sent show the assembly between the cuff and the tube and vyaire technician saw a little mark on the cuff.This little mark is normal and is made by leak tester.Physical sample was not returned for the evaluation, since the sample is needed to perform a dimensional inspection.The defect reported by the customer was not confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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