Model Number PATIENT CIRCUIT W/O PEEP, 22 MM SPU (10/PKG) |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2020 |
Event Type
Injury
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Manufacturer Narrative
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Vyaire file identification: (b)(4).The suspect device is not available for return since the customer stated that at this time the pandemic is requiring them to keep all consumables on hand.However, they sent a photograph of the product for evaluation.
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Event Description
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The customer reported that the patient circuit w/o peep, 22 mm spu (10/pkg) experienced connection issue.The proximal pressure line had sheared off.The line was in no way touched before the failure.The customer confirmed that there was no patient harm associated with the reported event.The patient was removed from the circuit and hand ventilated.Placed on a different ventilator with a different circuit.
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Manufacturer Narrative
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Photo investigation: according to the photo investigation, there was damage of l-fitting port which could be caused by applying of external abnormal force during assembly process.The damage of l-fitting port was caused by mishandling of circuit products during the assembly process and the work instruction mwi-as-1064/b did not specify handling requirement on guiding the worker to transmit and handle the circuit during the process.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Search Alerts/Recalls
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