Catalog Number 002061 |
Device Problems
Disconnection (1171); Loose or Intermittent Connection (1371)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Date 06/26/2019 |
Event Type
Injury
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Manufacturer Narrative
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Vyaire had reached out to the customer to request the complaint device for further investigation.However, customer stated that device was not available.If any additional information becomes available a follow up emdr will be submitted.
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Event Description
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A customer reported to vyaire that the adapters were "popping off" and causing leaks in the circuit while connected to a patient.The t-piece was used to connect the patient to the ventilator.The massive leak caused the vent alarms to go off.When the respiratory therapist (rt) arrived, the disconnected spring piece was found on the patient's bed with the t-piece still connected between the ventilator and the patient.The patient experienced low saturations in the 50% range and difficulty breathing.The customer confirmed that there was no patient compromise as they were alerted to the leak and quickly re-connected valve.
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Manufacturer Narrative
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A sample or lot number was not returned; however, the manufacturer reviewed it's process based on the available information and determined the cause to be the manufacturer assembly process and operator error.Corrective actions were indicated.
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Search Alerts/Recalls
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