VYAIRE MEDICAL VITAL SIGNS¿ LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Model Number ANES CIRCUIT, ADULT, 72 IN LIMBO, 3L BAG |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H3: 81 other - customer did not send a physical sample or pictures of the fg (b)(6).X with lot number unknown for the investigation.We require a physical sample or pictures to perform a better investigation and determine the reported defect and the root cause.In addition, the device history record is reviewed as part of the investigation.However, since the lot number was not provided this was not possible.Therefore, the reported defect 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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Event Description
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It was reported to vyaire medical that during use on patient, leak occurred on from anes circuit, adult, 72 in limbo, 3l bag.At this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.
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Search Alerts/Recalls
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