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, 108 IN LIMBO |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3: 81 other - at this time, no investigation was performed as the product was discarded by the hospital due to an infectious disease.Therefore, a definitive root cause could not 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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It was reported to vyaire medical that the blue connector on the inhale side and the white connector on the exhalation side (afpxxxxx-anes circuit, adult, 108 in limbo) are connected and used, respectively.The leak test passed without any problems.However, the white connector loosened during the procedure.However, the connector continued to pull out immediately when pulled until the end of the op.There was no particular problem with the blue connector.On follow-up, the customer confirmed that the operation went successfully, but until the end of the operation, the tube kept loose when it was pulled.The customer confirmed that there was no patient harm/injury associated with the event.
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Manufacturer Narrative
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Based on the investigation, since no pictures or physical samples were provided, we cannot confirm the reported defect.We require the physical sample and/or pictures as evidence to perform a better investigation and determine the cause of the reported issue.Additionally, quality personnel conducted a random sampling in one batch of gas elbow part number r5600eb (used for the manufacture of fg afpxxxxx), finding the component to be acceptable and within specification.In addition, the device history record of the fg part number afpxxxxx with lot number 0004246526 was reviewed, and no issues were found during its manufacturing.In addition, pfmea-56a-038 was reviewed, and controls were implemented for this type of defect. therefore, the root cause was not confirmed.
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